Ranibizumab for Diabetic Traction Retinal Detachment

Phase 2CompletedNCT01201161

University of Sao Paulo19 enrolled

Overview

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Retinopathy Retinal Detachment

Interventions

RanibizumabDRUG

Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

Sham injectionOTHER

Simulation of intravitreal injection one week before pars plana vitrectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy. Exclusion Criteria: * Massive vitreous hemorrhage preventing from detailed posterior pole examination; * Previous intra-ocular surgery other than cataract surgery * Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin * Prothrombin time, partial thromboplastin time or platelet count without normal limits * History of previous thromboembolic events

Locations (1)

University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

amount of intraoperative intra-ocular bleeding

amount of intra-ocular bleeding that occurred during pars plana vitrectomy

Time frame: one week

Secondary Outcomes

visual acuity

ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy

Time frame: 12 weeks

Data from ClinicalTrials.gov

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