Phase 3
N=939
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02462928 ↗Enrolled (actual)
939
Serious AEs
30.9%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With Stable Vision at Week 52 — 91.7; 91.2; 95.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abicipar Pegol (Drug); Ranibizumab (Drug); Sham Procedure (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Stable Vision at Week 52 |
91.7; 91.2; 95.5 | — |
| SECONDARY Mean Change From Baseline in BCVA in the Study Eye at Week 52 |
6.7; 5.6; 8.5 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 |
-141.5; -150.1; -141.3 | — |
| SECONDARY Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 |
22.6; 19.2; 27.2 | — |
| SECONDARY Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52 |
2.7; 3.7; 4.6 | — |
Summary
This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/40 to 20/320 in the study eye
- Best corrected visual acuity of 20/200 or better in the non-study eye
Exclusion Criteria
- History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
- Cataract or refractive surgery in the study eye within the last 3 months
Data sourced from ClinicalTrials.gov (NCT02462928). 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.