Viewing Study NCT00443521



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Study NCT ID: NCT00443521
Status: COMPLETED
Last Update Posted: 2007-03-06
First Post: 2007-03-02

Brief Title: Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: University of Sao Paulo
Organization: University of Sao Paulo

Study Overview

Official Title: Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Status: COMPLETED
Status Verified Date: 2007-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy
Detailed Description: The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation Therefore this study is designed using both treatments in the same patient intravitreal triamcinolone plus panretinal photocoagulation in one eye compared to panretinal photocoagulation alone in the contralateral eye These patients had their visual acuity measured and complete ophthalmological examination was performed including macular slit lamp examination fluorescein angiography and optical coherence tomography

Patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye For the triamcinolone injections numbing drops antibiotic drops and drops to dilate the pupil and possibly and anesthetic injection are put in the eye before the medicine is injected into the vitreous Patients return for follow-up visits 1 day 1 and 4 weeks after the injection and then 3 and 6 months Patients whose condition does not improve may undergo new evaluation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None