CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 253 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/NCT00464685
NCT00464685Phase 2Completed
CompareCT.gov

Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema

Allergan·interventional·Posted Apr 24, 2007·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Dexamethasone, Sham injection, and 1 other intervention for Diabetic Macular Edema. Completed, enrolled 253 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2007
Enrollment StartMay 1, 2007
Primary CompletionFeb 8, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.2 years ago

Interventions

Dexamethasonedrug

Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.

Sham injectiondrug

Initial sham injection with up to 1 additional treatment based on re-treatment criteria.

Laser Photocoagulationprocedure

Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.