This trial is active, not recruiting.

Condition diabetic retinopathy
Treatments ranibizumab and vitrectomy, vitrectomy without preoperative ranibizumab
Phase phase 2
Sponsor Attila Vajas
Collaborator Semmelweis University
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
ranibizumab and vitrectomy Lucentis intravitreal injection.
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
(Placebo Comparator)
Patients receiving sham treatment before vitrectomy as a comparator arm
vitrectomy without preoperative ranibizumab
sham intravitreal injection before vitrectomy surgery

Primary Outcomes

Efficacy of preoperative intravitreal ranibizumab
time frame: OP day

Secondary Outcomes

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.

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University of Debrecen.