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Sponsored by: |
Bausch & Lomb, Inc. |
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Information provided by: | Bausch & Lomb, Inc. |
ClinicalTrials.gov Identifier: | NCT00576459 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Drug: 0.59 mg fluocinolone acetonide intravitreal implant Drug: 2.1 mg fluocinolone acetonide intravitreal implant Procedure: standard of care laser photocoagulation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema |
Enrollment: | 40 |
Study Start Date: | March 2003 |
Study Completion Date: | July 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: 0.59 mg fluocinolone acetonide intravitreal implant
0.59 mg
|
2: Experimental |
Drug: 2.1 mg fluocinolone acetonide intravitreal implant
2.1 mg
|
3: Active Comparator |
Procedure: standard of care laser photocoagulation
standard of care laser photocoagulation
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
The Chinese University of Hong Kong | |
Hong Kong, China | |
India, Hyderabad | |
LV Prasad Eye Institute | |
Banjara Hills, Hyderabad, India, 500 034 |
Principal Investigator: | Taraprasad Das, MD | LV Prasad Eye Institute |
Principal Investigator: | Dennis Lam Shun-Chiu, MD | Chinese University of Hong Kong |
Responsible Party: | Bausch & Lomb ( Timothy L. Comstock ) |
Study ID Numbers: | 420-003 |
Study First Received: | December 18, 2007 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00576459 |
Health Authority: | United States: Food and Drug Administration; Hong Kong: Department of Health; India: Drugs Controller General of India |
Signs and Symptoms Macular Edema Fluocinolone Acetonide Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones Glucocorticoids Pharmacologic Actions |