drugset / Trial / NCT02121262

A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema

NCT02121262 ↗

Phase 3 Completed 284 enrolled Allergan Tigermed Consulting Co., Ltd · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser photocoagulation in participants with diabetic macular edema (DME).

Timeline

Start
2016-01-08
Primary completion
2019-11-01
Completion
2019-11-01

Outcome

Met primary endpoint

registry analysis (superiority test); Laser Photocoagulation vs Dexamethasone; p = 0.0011; Least Squares Mean (LSM) Difference 2.9 (95% CI 1.17 to 4.66); ANCOVA NCT02121262 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 700 ug Intravitreal