Trial | NCT00931125  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    70
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.
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 Started
Mar 31
2009
Primary Completion
Sep 30
2013
Study Completion
Dec 31
2013
Anticipated
Last Update
Oct 16
2013
Estimate

Drug ranibizumab and vitrectomy

ranibizumab 10mg/ml intravitreal injection, 0,05 ml

  • Other names: Lucentis intravitreal injection.

Procedure vitrectomy without preoperative ranibizumab

sham intravitreal injection before vitrectomy surgery

vitrectomy with ranibizumab Active Comparator

Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery

vitrectomy without ranibizumab Placebo Comparator

Patients receiving sham treatment before vitrectomy as a comparator arm

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
No Results Posted