Phase 2
Completed N=123
A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
Macular Degeneration
Source: ClinicalTrials.gov NCT03539549 ↗
Enrolled (actual)
123
Serious AEs
13.0%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Stable Vision — 97.6 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Stable Vision |
97.6 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye |
-82.5 | — |
| SECONDARY Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye |
0.9 | — |
| SECONDARY Change Form Baseline in BCVA in the Study Eye |
3.6 | — |
| SECONDARY Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye |
9.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03539549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.