CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 159 enrolled
Drug / intervention
aflibercept injection (VEGF Trap-Eye, BAY86-5321) +4 morebiological
Likely dose
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00320788
NCT00320788Phase 2Completed
CompareCT.gov

A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

Regeneron Pharmaceuticals·interventional·Posted May 3, 2006·Updated Mar 1, 2012

In Brief

A Phase 2 clinical trial evaluating aflibercept injection (VEGF Trap-Eye, BAY86-5321) for Macular Degeneration. Completed, enrolled 159 participants across 18 sites.

Detailed Summary

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Degeneration
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 3, 2006
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.2 years ago

Interventions

aflibercept injection (VEGF Trap-Eye, BAY86-5321)biological

Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12

aflibercept injection (VEGF Trap-Eye, BAY86-5321)biological

Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

aflibercept injection (VEGF Trap-Eye, BAY86-5321)biological

Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12

aflibercept injection (VEGF Trap-Eye, BAY86-5321)biological

Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

aflibercept injection (VEGF Trap-Eye, BAY86-5321)biological

Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.