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

Phase 2

• Conditions: Diabetic Retinopathy
• Interventions: Procedure: vitrectomy without preoperative ranibizumab; Drug: ranibizumab and vitrectomy

• Registration Number: NCT00931125
• Lead Sponsor: Attila Vajas

Brief 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.

Detailed Description

This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Primary Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-14
• Last Update Posted: 2013-10-16
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitrectomy without ranibizumab	vitrectomy without preoperative ranibizumab	Patients receiving sham treatment before vitrectomy as a comparator arm
vitrectomy with ranibizumab	ranibizumab and vitrectomy	Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery

Primary Outcome Measures

Name	Time	Method
Efficacy of preoperative intravitreal ranibizumab	OP day	Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy

Secondary Outcome Measures

Name	Time	Method
Change in BCVA.	6 months
Effect in anatomical changes.	3 ±1 days after injection
Retinal circulation integrity.	Month 1, 3, 6.	Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
Safety.	Over 6 months.

Trial Locations

Locations (1)

University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology; 🇭🇺 Debrecen, Hungary