A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema

Alimera Sciences0 sites956 target enrollmentSeptember 2007

ConditionsDiabetic Macular Edema

InterventionsFluocinolone Acetonide Standard of care laser photocoagulation

Drugsfluocinolone acetonide Fluocinolone Acetonide

Overview

Phase: Phase 3
Intervention: Fluocinolone Acetonide
Conditions: Diabetic Macular Edema
Sponsor: Alimera Sciences
Enrollment: 956
Primary Endpoint: Visual Acuity
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

December 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alimera Sciences

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

1

Intervention: Fluocinolone Acetonide

2

Intervention: Fluocinolone Acetonide

3

Intervention: Standard of care laser photocoagulation

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: 36 months

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).