CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 243 enrolled
Drug / intervention
dexamethasone +2 moredrug
Likely dose
dexamethasone 700 µgfrom 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/NCT00511706
NCT00511706Phase 2Completed
CompareCT.gov

Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

Allergan·interventional·Posted Aug 6, 2007·Updated Apr 25, 2019

In Brief

A Phase 2 clinical trial evaluating dexamethasone, ranibizumab, and 1 other intervention for Choroidal Neovascularization and Age-Related Maculopathy. Completed, enrolled 243 participants across 9 sites in 9 countries.

Detailed Summary

The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChoroidal Neovascularization, Age-Related Maculopathy
CountriesAustralia, France, Israel, Italy, New Zealand, Portugal, South Korea, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2007
Enrollment StartNov 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.9 years ago

Interventions

dexamethasonedrug

Intravitreal injection of dexamethasone 700 µg at Day 1.

ranibizumabbiological

Ranibizumab 500 µg at day -30 and Day 7-14.

shamother

Sham needle-less injection administered in the study eye at Day 1.