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COMPLETED
NCT02556424
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2016-01

Completion Date

2021-02-15

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Intravitreal implant at D0

DRUG

Triamcinolone

Subconjunctival injection at 4 mm from the limbus at 6 o'clock

Locations (16)

CHU Angers

Angers, France

CHU de Bordeaux

Bordeaux, France

CHU de Brest

Brest, France

CHU de Dijon

Dijon, France

CHU de Grenoble

La Tronche, France

Hôpital Bicêtre (AP-HP)

Le Kremlin-Bicêtre, France

CHRU de Lille

Lille, France

Hopices Civils de Lyon

Lyon, France

CHU de Montpellier

Montpellier, France

CHU de Nantes

Nantes, France

CHU de Nice

Nice, France

Hôpital La Pitié-Salpêtrière (AP-HP)

Paris, France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, France

CHU de Tours

Tours, France

CHU de Nancy

Vandœuvre-lès-Nancy, France