Phase 3
N=949
Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02462486 ↗Enrolled (actual)
949
Serious AEs
27.1%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With Stable Vision at Week 52 — 94.8; 91.3; 96.0 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 |
94.8; 91.3; 96.0 | — |
| SECONDARY Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52 |
8.3; 7.3; 8.3 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 |
-146.8; -141.7; -147.1 | — |
| SECONDARY Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52 |
28.2; 24.4; 26.7 | — |
| SECONDARY Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52 |
2.8; 2.4; 4.4 | — |
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 (NCT02462486). 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.