Visual AcuityPhase 2PRELUDENCT02659098

A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy

A Phase 2 study testing CNTO 2476 3.0 x 10^5 cells and Subretinal Delivery System in people with Visual Acuity and Geographic Atrophy, run by Janssen Research & Development, LLC at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System. Read more about this study

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Visual Acuity, Geographic Atrophy, Macular Degeneration
What is being tested?: CNTO 2476 3.0 x 10^5 cells and Subretinal Delivery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 8 sitesUnited States
Study dates: 4 Dec 2015to 5 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center
Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye
Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable
Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

Who cannot join

Participant has a history of neovascular ("wet") AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening
Geographic atrophy secondary to any causes other than AMD in either eye
A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded
Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye
Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4 diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Arcadia, California
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Lexington, Kentucky
Study site
Philadelphia, Pennsylvania
Study site
Royal Oak, Michigan

Other trials in United States

About this study

Official title: A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Read the detailed description

This is a multicenter (when more than one hospital or medical school team work on a medical research study) study which includes an initial unmasked safety phase. The duration of participation in the study for each participant is approximately 3 years. Efficacy will be evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be monitored throughout the study.

Conditions: Visual Acuity, Geographic Atrophy, Macular Degeneration
Being tested: CNTO 2476 3.0 x 10^5 cells, Subretinal Delivery System
Keywords: Best Corrected Visual Acuity, Geographic Atrophy, Macular Degeneration, CNTO 2476
Medical subject headings: Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CNTO 2476 3.0 x 10^5 cellsDrug
Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
Subretinal Delivery SystemDevice
Participants will receive CNTO 2476 by using the Delivery System.

Study groups in NCT02659098
Study group	Role	What they receive
Open-Label Safety Run-in Phase: Treatment Group	Experimental	Participants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System. Receives: Drug: CNTO 2476 3.0 x 10^5 cells; Device: Subretinal Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 1
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 2
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 3
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 6
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 12
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 18
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 24
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 30
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 36
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 1
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 2
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 3
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 6
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 12
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 18
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 24
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 30
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline and Month 36

Secondary outcomes (8)

Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing >=15 BCVA in the study eye were reported.
Measured: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. The percentage of participants losing >=15 BCVA in the fellow eye were reported.
Measured: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye (Treated eye). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Measured: Baseline, Months 6 and 12
Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
BCVA was assessed as letters read using early treatment diabetic retinopathy study charts and reported as the number of letters read correctly (ranging from 0 to 100 letters) in the fellow eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Measured: Baseline, Months 6 and 12
Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye
The area of GA was determined based primarily on fundus autofluorescence (FAF). The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Measured: Baseline, Months 6 and 12
Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye
The area of GA was determined based primarily on FAF. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Measured: Baseline, Months 6 and 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with TEAEs and SAEs were assessed. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is a suspected transmission of any infectious agent via a medicinal product.
Measured: Up to Months 36
Number of Participants With Ocular Treatment-emergent Adverse Events
Number of participants with ocular TEAE were assessed. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment and can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Measured: Up to Months 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 20155 Jun 2019

First posted20 Jan 2016 (estimated)
Study start4 Dec 2015
Primary completion5 Jun 2019
Study completion5 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Visual AcuityStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659098
Sponsor's protocol ID: CR106814
Other IDs: CNTO2476MDG2002
Acronym: PRELUDE
Status last verified: Apr 2025
First submitted: 7 Dec 2015
Last updated: 29 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment

All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration
ClinicalTrials.gov ID: NCT02659098
Acronym / sponsor ID: PRELUDE / CR106814
Conditions: Visual Acuity, Geographic Atrophy, Macular Degeneration
Keywords: Best Corrected Visual Acuity, Geographic Atrophy, Macular Degeneration, CNTO 2476
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 4 Dec 2015 (actual)
Primary completion: 5 Jun 2019 (actual)
Study completion: 5 Jun 2019 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 23 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and performance profile of the suprachoroidal surgical approach and the Delivery System.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open-Label Safety Run-in Phase: Treatment Group	Experimental	Drug: CNTO 2476 3.0 x 10^5 cells, Device: Subretinal Delivery SystemParticipants will receive CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL). CNTO 2476 will be delivered using the custom-designed Delivery System.

Who may qualify

Ages: 55 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) confirmed within 45 days prior to initial randomization verified by the central reading center
Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the study eye
Participant is a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures. Participant has met criteria of the surgery center anti-coagulation protocol, if applicable
Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

Key exclusion criteria (5 listed)

Participant has a history of neovascular ("wet") AMD in the treatment eye, including evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization or fluid. In cases where imaging is inconclusive, review of the case with the study site, considering history and imaging will determine eligibility. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening
Geographic atrophy secondary to any causes other than AMD in either eye
A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to (>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive drug. Treatment should be no more than 1 drug preparation/combination, which can contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than 2 ocular hypotensive active ingredients are excluded
Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic condition that reduces the clarity of the media that, in the opinion of the investigator or reading center, interferes with ophthalmologic examination (example, corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study eye
Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4 diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CNTO 2476 3.0 x 10^5 cellsParticipants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.	Drug	Open-Label Safety Run-in Phase: Treatment Group
Subretinal Delivery SystemParticipants will receive CNTO 2476 by using the Delivery System.	Device	Open-Label Safety Run-in Phase: Treatment Group

Primary outcome

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
Time frame: Baseline and Month 1
Best corrected visual acuity (BCVA) was assessed in the study eye (Treated eye). BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
Time frame: Baseline and Month 2
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
Time frame: Baseline and Month 3
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
Time frame: Baseline and Month 6
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
Time frame: Baseline and Month 12
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
Time frame: Baseline and Month 18
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
Time frame: Baseline and Month 24
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
Time frame: Baseline and Month 30
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
Time frame: Baseline and Month 36
BCVA was assessed in the study eye (Treated eye). BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
Time frame: Baseline and Month 1
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
Time frame: Baseline and Month 2
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
Time frame: Baseline and Month 3
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
Time frame: Baseline and Month 6
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
Time frame: Baseline and Month 12
BCVA was assessed in the fellow eye. BCVA measurements were made using logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
Time frame: Baseline and Month 18
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
Time frame: Baseline and Month 24
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
Time frame: Baseline and Month 30
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
Time frame: Baseline and Month 36
BCVA was assessed in the fellow eye. BCVA measurements were made using the logMAR visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there were 5 letters per line, the total score for a line on the logMAR chart represented a change of 0.1 log units. The formula for calculating the logMAR BCVA score was: 1.7 - 0.02*number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.

8 secondary outcomes

Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye
Time frame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
Time frame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
Time frame: Baseline, Months 6 and 12
Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
Time frame: Baseline, Months 6 and 12
Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye
Time frame: Baseline, Months 6 and 12
Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye
Time frame: Baseline, Months 6 and 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Months 36
Number of Participants With Ocular Treatment-emergent Adverse Events
Time frame: Up to Months 36

Results and safety

Results posted to the registry on 23 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CNTO 2476 3.0*10^5 Cells	21	14

Primary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye

Time frame: Baseline and Month 1. Mean (Standard Deviation). Unit: logMAR

Measure	CNTO 2476 3.0*10^5 Cells n = 21
Value	0.132 (0.2093)

Population analysed: The safety analysis set defined as participants who were enrolled and received surgery in the study.

Primary outcome: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye

Time frame: Baseline and Month 2. Mean (Standard Deviation). Unit: logMAR

Measure	CNTO 2476 3.0*10^5 Cells n = 21
Value	0.073 (0.2273)

Population analysed: The safety analysis set defined as participants who were enrolled and received surgery in the study.

Primary outcome: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye

Time frame: Baseline and Month 3. Mean (Standard Deviation). Unit: logMAR

Measure	CNTO 2476 3.0*10^5 Cells n = 21
Value	0.079 (0.2502)

Population analysed: The safety analysis set defined as participants who were enrolled and received surgery in the study.

Primary outcome: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: logMAR

Measure	CNTO 2476 3.0*10^5 Cells n = 21
Value	0.090 (0.2628)

Population analysed: The safety analysis set defined as participants who were enrolled and received surgery in the study.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CNTO 2476 3.0*10^5 Cells	5 of 21 (23.8%)	18 of 21 (85.7%)	0 of 21

Limitations and caveats (from the sponsor): Protocol Amendment 3 eliminated 2nd safety cohort and randomized masked portion of study per Sponsor decision to terminate development. Protocol specified follow-up visits were completed for treated participants, thus study was considered completed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye (time frame: Baseline and Month 1). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.