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

University of Sao Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Retinopathy

Treatments: Drug: Triamcinolone Acetonide 4 mg intravitreal injection; Procedure: Panretinal photocoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00443521

310/05

Details and patient eligibility

About

The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Full 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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)