Macular DegenerationPhase 1/2NCT02228304
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
A Phase 1/2 study testing NT-503-3 ECT implantation and Eylea® injected intravitreally administered every 8 weeks in people with Macular Degeneration, run by Neurotech Pharmaceuticals at 38 sites in 2 countries.
Trial summary
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- NT-503-3 ECT implantation and Eylea® injected intravitreally administered every 8 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Sep 2014to Apr 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
- Prior Intravitreal Anti-VEGF injections
Who cannot join
- Significant subretinal hemorrhage
- Significant Scar and/or, fibrosis
- Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
- Inadequate response to anti-VEGF therapy
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States32 sites
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105
Western Carolina Retinal Associates
Asheville, North Carolina, 28803
Southeast Retina Center, PC
Augusta, Georgia, 30909
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina Center of New Jersey, LLC
Bloomfield, New Jersey, 07003
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
The Retina Group of Washington
Chevy Chase, Maryland, 20815
Cleveland Clinic
Cleveland, Ohio, 44195
Palmetto Retina Center, LLC
Florence, South Carolina, 29501
Retina Health Center
Fort Myers, Florida, 33907
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Colorado Retina Associates
Golden, Colorado, 80401
Cumberland Valley Retina Consultants, PC
Hagerstown, Maryland, 21740
University of California, Irvine, The Gavin Herbert Eye Institute
Irvine, California, 92697
Illinois Retina Associates, S.C.
Joliet, Illinois, 60435
Jacobs Retina Center at UCSD
La Jolla, California, 92093
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Georgina Retina, P.C.
Marietta, Georgia, 30060
Valley Retina Institute, PA
McAllen, Texas, 78503
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NJ Retina
New Brunswick, New Jersey, 08901
Illinois Retina Associates
Oak Park, Illinois, 60304
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Retina Northwest, PC
Portland, Oregon, 97210
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Sierra Eye Associates
Reno, Nevada, 89502
William Beaumont Hospital-Ophthalmology Research
Royal Oak, Michigan, 48073
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, 27157
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Israel6 sites
Soroka Medical Center
Beersheba
Hadassah-Hebrew University Medical Center
Jerusalem, 91120
Meir Medical Center
Kfar Saba, 44281
Rabin Medical Center
Petah Tikva, 49100
Kaplan Medical Center
Rehovot, 76100
Sourasky Medical Center,
Tel Aviv, 64239
About this study
Official title: A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.
Clinical Hypotheses:
- NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD
- NT-503-3 ECT has an acceptable safety profile
- Conditions
- Macular Degeneration
- Being tested
- NT-503-3 ECT implantation, Eylea® injected intravitreally administered every 8 weeks
- Keywords
- Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-503-3 ECT implantationDrug
NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
Eylea® injected intravitreally administered every 8 weeksDrug
The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.
| Study group | Role | What they receive |
|---|---|---|
| NT-503-3 ECT implantation | Experimental | Not described Receives: Drug: NT-503-3 ECT implantation |
| Eylea® injected intravitreally every 8 weeks | Active comparator | Eylea® injected intravitreally every 8 weeks Receives: Drug: Eylea® injected intravitreally administered every 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
Measured: Week 52 and Week 108
Secondary outcomes (3)
Change from baseline in best corrected visual acuity (BCVA)
Measured: Week 52
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
Measured: Up to Week 108
Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
Measured: Up to Week 108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Johnson, MB, ChB, Study chair, Neurotech Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228304
- Sponsor's protocol ID
- NT-503-3-AMD-001
- Status last verified
- Jul 2022
- First submitted
- 27 Aug 2014
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD
- ClinicalTrials.gov ID
- NCT02228304
- Acronym / sponsor ID
- NT-503-3-AMD-001
- Conditions
- Macular Degeneration
- Keywords
- Wet AMD, Wet Age Related Macular Degeneration, Recurrent CNV Secondary to AMD, Active subfoveal CNV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Neurotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2. Those who, in the opinion of the investigator, are still candidates for continued anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate, randomized, masked phase during which eligible patients will be randomized to the NT-503-3 group or the control group.
Clinical Hypotheses:
- NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the prevention of vision loss due to recurrent CNV secondary to AMD
- NT-503-3 ECT has an acceptable safety profile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT-503-3 ECT implantation | Experimental | Drug: NT-503-3 ECT implantation |
| Eylea® injected intravitreally every 8 weeks | Active comparator | Drug: Eylea® injected intravitreally administered every 8 weeksEylea® injected intravitreally every 8 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD in the study eye
- Prior Intravitreal Anti-VEGF injections
Key exclusion criteria (4 listed)
- Significant subretinal hemorrhage
- Significant Scar and/or, fibrosis
- Suspected polypoidal choroidopathy, or pigment epithelial tears or rips
- Inadequate response to anti-VEGF therapy
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 |
|---|---|---|
| NT-503-3 ECT implantationNT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy | Drug | NT-503-3 ECT implantation |
| Eylea® injected intravitreally administered every 8 weeksThe first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study. | Drug | Eylea® injected intravitreally every 8 weeks |
Primary outcome
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
Time frame: Week 52 and Week 108
3 secondary outcomes
Change from baseline in best corrected visual acuity (BCVA)
Time frame: Week 52
Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
Time frame: Up to Week 108
Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
Time frame: Up to Week 108
Results and safety
The study was stopped early (reason given: After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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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.
Charles Johnson, MB, ChB study chair
Neurotech Pharmaceuticals, Inc.
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NT-503-3 ECT implantation and Eylea® injected intravitreally administered every 8 weeks in people with Macular Degeneration, run by Neurotech Pharmaceuticals at 38 sites in 2 countries.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping criteria.). Results are not available in the source record.
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?
Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters (time frame: Week 52 and Week 108). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2022.