Phase 3
Completed N=323
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Source: ClinicalTrials.gov NCT00964795 ↗Enrolled (actual)
323
Serious AEs
32.5%
Results posted
Mar 2015
Primary outcomePrimary: Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD — 290; 239; 204; 169 participants
Summary
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD |
290; 239; 204; 169; 232; 105 | — |
| SECONDARY Change in BCVA Letter Score (mLOCF) |
-2.7 | — |
Eligibility Criteria
Inclusion Criteria
- Participation in Study VGFT-OD-0605 through week 96.
- In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.
Exclusion Criteria
- Presence of any condition that would jeopardize the patient's participation in this study.
- Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
Data sourced from ClinicalTrials.gov (NCT00964795). 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.