drugset / Trial / NCT02556424

Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema

NCT02556424

Phase 3 Completed 114 enrolled Nantes University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label. In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.

Timeline

Start
2016-01
Primary completion
2021-02-15
Completion
2021-02-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 700 ug Intravitreal
Subject Triamcinolone Other / unclassified 16 mg

Indications