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

NCT00344968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 956

Last updated 2014-05-07

Study results available
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Summary

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

Conditions

Interventions

DRUG

fluocinolone acetonide

0.5 mg fluocinolone acetonide intravitreal insert

DRUG

Fluocinolone Acetonide

0.2 mg fluocinolone acetonide intravitreal insert

PROCEDURE

Standard of care laser photocoagulation

Laser photocoagulation

Sponsors & Collaborators

  • Alimera Sciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344968 on ClinicalTrials.gov