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Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular Edema

NCT00576459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-12-08

No results posted yet for this study

Summary

This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.

Conditions

Interventions

DRUG

0.59 mg fluocinolone acetonide intravitreal implant

0.59 mg

DRUG

2.1 mg fluocinolone acetonide intravitreal implant

2.1 mg

PROCEDURE

standard of care laser photocoagulation

standard of care laser photocoagulation

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Taraprasad Das, MD · LV Prasad Eye Institute

  • Dennis Lam Shun-Chiu, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-06-30
Completion
2006-07-31

Countries

  • China
  • India

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 NCT00576459 on ClinicalTrials.gov