Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy (IRaHi)

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Retinal Neovascularization; Diabetic Retinopathy

Treatments: Procedure: Panretinal Photocoagulation; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01102946

IRaHi

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• High risk proliferative diabetic retinopathy
• Visual acuity ≥ 20/800
• No previous laser treatment for diabetic retinopathy

Exclusion criteria

• Previous pars plana vitrectomy
• Systemic thrombo-embolic events
• Uncontrolled systemic hypertension
• Conditions avoiding adequated documentation
• Previous eye surgery in the last 6 months before inclusion in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

PRP plus ranibizumab

Experimental group

Description:

Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

Treatment:

Procedure: Panretinal Photocoagulation

Drug: Ranibizumab

PRP

Active Comparator group

Description:

Patients will only be submitted to panretinal photocoagulation

Treatment:

Procedure: Panretinal Photocoagulation