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

NCT ID: NCT00443521

Last Updated: 2007-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-07-31

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.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Triamcinolone Acetonide 4 mg intravitreal injection

Intervention Type: DRUG

Panretinal photocoagulation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Principal Investigators

Otacílio O Maia Júnior, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Walter Y Takahashi, M.D.

Role: STUDY_DIRECTOR

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

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

310/05

Identifier Type: -

Identifier Source: org_study_id