Phase 2
N=25
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02181517 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Apr 2016
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale — 55.2; 59.0; 57.6; 4.4 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- abicipar pegol (Drug); ranibizumab (Drug); sham procedure (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale |
55.2; 59.0; 57.6; 4.4; 10.1; 15.2 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale |
55.2; 59.0; 57.6; 5.6; 6.7; 14.4 | — |
| SECONDARY Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale |
30.0; 30.0; 60.0 | — |
| SECONDARY Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale |
40.0; 40.0; 60.0 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye |
443.8; 383.8; 348.8; -106.5; -112.8; -124.4 | — |
Summary
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of wet age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion Criteria
- Hypersensitivity, allergy, or anaphylactic reaction to iodine
- Cataract or refractive surgery within the last 3 months
- History of vitrectomy
Data sourced from ClinicalTrials.gov (NCT02181517). 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.