Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Phase 2

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT00443521
• Lead Sponsor: University of Sao Paulo

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 Timeline

• Study Start: 2005-03
• Study Completion: 2006-07
• Status Verified: 2007-03
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Last Update Submitted: 2007-03-02
• Study First Posted: 2007-03-06
• Last Update Posted: 2007-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type II Diabetes
• symmetric proliferative diabetic retinopathy without high risk characteristics
• Informed consent signed

Exclusion Criteria

• previous treatment for diabetic retinopathy
• media opacities that may interfere with clinical, photographically or OCT examinations
• inability to understands the implications of the protocol
• Glaucoma or ocular hypertension
• Any other pathology that could cause retinal alterations
• Patients with any other situation that may interfere in study completion based in Investigator´s opinion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual acuity (ETDRS)
Optic coherence tomography
Vitreous haemorrhage

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerance of the treatment

Trial Locations

Locations (1)

Retina and Vitreous Service, Department of Ophthalmology. Hospital das Clínicas. University of São Paulo School of Medicine; 🇧🇷 São Paulo, Brazil