Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Bausch + Lomb

Status and phase

Completed

Phase 3

Phase 2

Conditions

Diabetic Macular Edema

Treatments

Drug: fluocinolone acetonide

Procedure: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT00502541

CDS FL-005

Details and patient eligibility

About

This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Enrollment

196 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and nonpregnant females at least 18 years of age, with DME in the study eye
Edema must involve fixation and be at least 1 disc area in size
Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study
Ability and willingness to comply with treatment and follow-up
Ability to understand and sign the Informed Consent form

Exclusion criteria

Pregnant, lactating females
Allergy to fluocinolone acetonide or any component of the delivery system
Any disease or condition that would preclude study treatment or follow up
Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
History of uncontrolled IOP within the last 12 months