Phase 2
Completed N=25
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Macular Degeneration
Source: ClinicalTrials.gov NCT02181504 ↗
Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 58.5; 54.3; 55.8; 8.9 Letters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
58.5; 54.3; 55.8; 8.9; 7.8; 17.4 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
58.5; 54.3; 55.8; 9.6; 8.7; 17.2 | — |
| SECONDARY Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale |
20.0; 30.0; 60.0 | — |
| SECONDARY Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale |
50.0; 50.0; 80.0 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye |
438.7; 475.1; 470.0; -196.5; -187.3; -230.4 | — |
Eligibility Criteria
Inclusion Criteria
- Ethnically Japanese
- 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 or shellfish
- Cataract or refractive surgery within the last 3 months
- History of vitrectomy
Data sourced from ClinicalTrials.gov (NCT02181504). 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.