Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Naive Proliferative diabetic retinopathy eyes.

• Best Corrected-Visual Acuity at baseline > 20/320 in the study eye

• Patients with and without diabetic macular edema

• Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years.

• Women must be using effective contraception

• Ability to provide written informed consent.

• Indication of panretinal photocoagulation in both eyes

Exclusion Criteria:

• Vitreous hemorrhage or pre-retinal hemorrhage

• Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months

• Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.

• Cataract

• Any intraocular surgery within 6 months before trial enrollment

• Previous vitrectomy.

• Any of the following underlying systemic diseases:

• History or evidence of severe cardiac disease or previous thrombus-embolic event