Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
This trial is active, not recruiting.
|Treatments||ranibizumab and vitrectomy, vitrectomy without preoperative ranibizumab|
|Start date||March 2009|
|End date||September 2013|
|Trial size||70 participants|
|Trial identifier||NCT00931125, CRFB002AHU03T|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Efficacy of preoperative intravitreal ranibizumab
time frame: OP day
Change in BCVA.
time frame: 6 months
Effect in anatomical changes.
time frame: 3 ±1 days after injection
time frame: Over 6 months.
Retinal circulation integrity.
time frame: Month 1, 3, 6.
Male or female participants at least 18 years old.
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
|Official title||Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone|
|Principal investigator||Attila Vajas, MD|
|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.|
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