Phase 2
Completed N=157
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
Macular Degeneration
Source: ClinicalTrials.gov NCT00527423 ↗
Enrolled (actual)
157
Serious AEs
45.9%
Results posted
Jun 2013
Primary outcomePrimary: Number of Participants With Adverse Events (AE) — 154; 138; 151; 5 participants
Summary
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) |
154; 138; 151; 5; 72; 5 | — |
| SECONDARY Frequency (Number of Injections) |
6.0 | — |
| SECONDARY Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values |
4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Prior participation in VEGF Trap-Eye Phase I and II studies
Exclusion Criteria
- Any ocular or systemic adverse events that would preclude participation
- Presence of any condition that would jeopardize subject's participation
Data sourced from ClinicalTrials.gov (NCT00527423). 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.