Intravitreal Injection of Ranibizumab Versus Sham Before Vitrectomy in Patients With Proliferative Diabetic Retinopathy

Conditions

• Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  intravitreal injection of 0.5 mg ranibizumab before vitrectomy
• sham — DRUG
  sham intravitreal injection before vitrectomy
• pars plana vitrectomy — PROCEDURE
  surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.

Study Details

Certain percent of the eyes with proliferative diabetic retinopathymay require pars plana vitrectomy (PPV) due to vitreous haemorrhage, proliferative membrane, and tractional retinal detachment. This study will compare intravitreal injection of anti-vascular endothelial growth factor (ranibizumab) versus sham injection before vitrectomy for PDR. The main focus is to see if pre-operative injection of ranibizuman can reduce peri-operative hemorrahge related complications.

Key Dates

First listed

Aug 5, 2016

Start date

Jul 31, 2014

Status verified

Oct 2017

Primary completion

Sep 30, 2017

Completion

Sep 30, 2017

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ranibizumab
  Intravitreal Injection of 0.5 mg ranibizumabone week before vitrectomy.
• Sham Comparator: control
  Sham intravitreal injection one week before vitrectomy.

Primary Outcome Measure

perioperative hemorrhage of the surgical eye [ Time Frame: 3 month ]