Status:
UNKNOWN
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
Lead Sponsor:
Attila Vajas
Collaborating Sponsors:
Semmelweis University
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 diabe...
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 bef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00931125
Start Date
March 1 2009
End Date
December 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Debrecen, Hungary, H-4012