Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.

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

Details

• Lead Sponsor: Attila Vajas
• Collaborator: Semmelweis University
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• male or female 18 or older who have signed an informed consent

• Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation

• study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters

• study eye vision decrease must be resulted from severe PDR

Exclusion Criteria:

• Active ocular inflammation or infection

• History of uveitis

• Uncontrolled glaucoma

• High myopia

• Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results

• Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye

• History of vitrectomy within 60 days preceding Day 1 in the study eye

• History of intraocular surgery within 30 days preceding Day 1 in the study eye

• Untreated diabetes mellitus

• Severe hypertension (systolic pressure higher than 160mmHg)

• Current use of systemic medications known to be toxic to the retina

• History of thromboembolic events (incl MI and stroke) within 5 years

• Major surgery within previous 3 months or planned within the next 28 days

• Known coagulation abnormalities or current use of anticoagulative medications other than aspirins

• Known hypersensitivity to ranibizumab or any component of it

• Women of childbearing potential unless 2 methods of birth control applied

• Pregnant or lactating women