drugset / Trial / NCT02902744

Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study

NCT02902744 ↗

Phase 4 Withdrawn Johns Hopkins University
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: • To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME). Secondary Objectives: • To collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Timeline

Start
2017-03-01
Primary completion
2017-08-18
Completion
2017-08-18

Outcome

Outcome not reported

Stopped (Enrollment): “The study was withdrawn due to difficult recruitment of patients for the study; No participants were enrolled in the study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject fluocinolone acetonide Other / unclassified 0.19 mg Intravitreal