CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Dexamethasone intravitreal implant (0.7 mg) +1 moredrug
Likely dose
Dexamethasone intravitreal implant (0.7 mg)from 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/NCT02471651
NCT02471651Phase 4Completed

Dexamethasone Intravitreal Implant (0.7mg) for the Treatment of Persistent Diabetic Macular Edema Following Intravitreal Anti-Vascular Endothelial Growth Factor Therapy

California Retina Consultants·interventional·Posted Jun 15, 2015·Updated Feb 19, 2019

In Brief

A Phase 4 clinical trial evaluating Dexamethasone intravitreal implant (0.7 mg) and Intravitreal anti-VEGF injection for Diabetic Macular Edema. Completed, enrolled 40 participants across 4 sites.

Detailed Summary

Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly used treatment options for individuals with diabetic macular edema. However, some patients continue to experience persistent diabetic macular edema and poor vision despite continued laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth factor injections. The purpose of this research study is to compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for research participants with persistent diabetic macular edema (DME).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 15, 2015
Enrollment StartJun 1, 2015
Primary CompletionOct 24, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.0 years ago

Interventions

Dexamethasone intravitreal implant (0.7 mg)drug

Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).

Intravitreal anti-VEGF injectiondrug

This injection may be ranibizumab, bevacizumab, or aflibercept.