Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

Alimera Sciences956 enrolled

Overview

This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

956

Conditions

Diabetic Macular Edema

Interventions

fluocinolone acetonideDRUG

0.5 mg fluocinolone acetonide intravitreal insert

Fluocinolone AcetonideDRUG

0.2 mg fluocinolone acetonide intravitreal insert

Standard of care laser photocoagulationPROCEDURE

Laser photocoagulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>= 18 years with diabetic macular edema * Diagnosis of diabetes mellitus types 1 or 2 * Best corrected visual acuity of 19-68 letters * Retinal thickness \> 250 micron by OCT * Investigator is comfortable deferring macular laser treatment for 6 weeks Exclusion Criteria: * Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents * Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy * Prior intravitreal, subtenon, or periocular steroid therapy within 6 months * Any ocular surgery within the last 3 months * Retinal laser treatment within the last 3 months * History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy * Any lens opacity which impairs visualization of the posterior pole

Locations (1)

Unnamed facility

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Visual Acuity

The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).

Time frame: 36 months

Secondary Outcomes

Retinal Thickness

Retinal images where sent to a reading center for analysis. Some images were not clear/distorted and could not be properly analyzed. This accounts for the discrepancy in the number of participants analyzed.

Time frame: 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.