Macular DegenerationPhase 2NCT03539549

A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)

A Phase 2 study testing Abicipar pegol in people with Macular Degeneration, run by Allergan at 37 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 objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD). 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?: Abicipar pegol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 37 sitesUnited States
Study dates: 25 May 2018to 27 Feb 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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female participants, 50 years of age or older at the time of informed consent
Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Who cannot join

Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
Previous or concurrent macular laser treatment (study eye)
Cataract or refractive surgery within 3 months prior to baseline (study eye)

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Retina Research Institute of Texas
Abilene, Texas, 79606
Capital Region Retina, PLLC
Albany, New York, 12206
Win Retina
Arcadia, California, 91006
Texas Retina Associates
Arlington, Texas, 76012
Austin Retina Associates
Austin, Texas, 78705
Texan Eye
Austin, Texas, 78731
Gailey Eye Clinic
Bloomington, Illinois, 61704
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, 17011
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Retina Consultants of Orange County
Fullerton, California, 92835
Mark B. Kislinger, MD, Inc.
Glendora, California, 91741
Colorado Retina Associates
Golden, Colorado, 80401
Retinal Consultants of Houston
Houston, Texas, 77030
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, 92647
Raj K. Maturi, MD, PC
Indianapolis, Indiana, 46290
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Sabates Eye Center
Leawood, Kansas, 66211
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11580
Georgia Retina, P.C.
Marietta, Georgia, 30060
Marietta Eye Clinic
Marietta, Georgia, 30060
Premiere Retina Specialists
Midland, Texas, 79706
N. California Retina Vitreous Associates Medical Group, INC.
Mountain View, California, 94040
California Eye Specialists Medical Group, Inc
Pasadena, California, 91107
Retina Specialty Institute
Pensacola, Florida, 32503
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Sierra Eye Associates
Reno, Nevada, 89502
Retina Institute of Virginia
Richmond, Virginia, 23235
Retina Associates of Western New York
Rochester, New York, 14620
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95819
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina Vitreous Surgeons of Central NY, P.C.
Syracuse, New York, 13224
Retina Consultants of Houston
The Woodlands, Texas, 77384
Retina Associates Southwest, PC
Tucson, Arizona, 85710
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
Center for Retina and Macular Disease
Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Conditions: Macular Degeneration
Being tested: Abicipar pegol
Medical subject headings: Macular Degeneration

What participants receive

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

Abicipar pegolDrug
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.

Study groups in NCT03539549
Study group	Role	What they receive
Abicipar pegol 2 mg	Experimental	Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24. Receives: Drug: Abicipar pegol

What is being measured

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

Percentage of Participants With Stable Vision
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Measured: Baseline (Day 1) to Week 28

Secondary outcomes (4)

Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Measured: Baseline (Day 1) to Week 28
Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Measured: Baseline (Day 1) to Week 28
Change Form Baseline in BCVA in the Study Eye
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Measured: Baseline (Day 1) to Week 28
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Measured: Baseline (Day 1), Week 28

Timeline

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

25 May 201827 Feb 2019

First posted29 May 2018
Study start25 May 2018
Primary completion27 Feb 2019
Study completion27 Feb 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 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03539549
Sponsor's protocol ID: 1771-201-008
Status last verified: Jul 2020
First submitted: 17 May 2018
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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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All Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT03539549
Acronym / sponsor ID: 1771-201-008
Conditions: Macular Degeneration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 25 May 2018 (actual)
Primary completion: 27 Feb 2019 (actual)
Study completion: 27 Feb 2019 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 3 Aug 2020

Clinical summary

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

The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Study design

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

Arm	Type	Receives
Abicipar pegol 2 mg	Experimental	Drug: Abicipar pegolAbicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female participants, 50 years of age or older at the time of informed consent
Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye

Key exclusion criteria (3 listed)

Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
Previous or concurrent macular laser treatment (study eye)
Cataract or refractive surgery within 3 months prior to baseline (study eye)

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
Abicipar pegolAbicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.	Drug	Abicipar pegol 2 mg

Primary outcome

Percentage of Participants With Stable Vision
Time frame: Baseline (Day 1) to Week 28
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.

4 secondary outcomes

Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline (Day 1) to Week 28
Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
Time frame: Baseline (Day 1) to Week 28
Change Form Baseline in BCVA in the Study Eye
Time frame: Baseline (Day 1) to Week 28
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
Time frame: Baseline (Day 1), Week 28

Results and safety

Results posted to the registry on 3 Aug 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
Abicipar Pegol 2 mg	123	106

Primary outcome: Percentage of Participants With Stable Vision

Time frame: Baseline (Day 1) to Week 28. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Abicipar Pegol 2 mg n = 123
Value	97.6 (94.2 to 99.8)

Population analysed: Safety Population included all participants who received at least 1 administration of study treatment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose up to 28 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abicipar Pegol 2 mg	16 of 123 (13%)	0 of 123 (0%)	2 of 123

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Macular Degeneration

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Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
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Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
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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.

Joanne Li, MD study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abicipar pegol in people with Macular Degeneration, run by Allergan at 37 sites in United States.

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 3 inclusion and 3 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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 3 Aug 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?

Percentage of Participants With Stable Vision (time frame: Baseline (Day 1) to Week 28). 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 NCT03539549.

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 3 Aug 2020.