Clinical trial NCT00931125: Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Retinopathy
Keywords: Severe proliferative diabetic retinopathy
Lead sponsor: University of Debrecen
Sponsor class: OTHER
Collaborators: name: Semmelweis University
First posted: 2009-07-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of preoperative intravitreal ranibizumab
timeFrame: OP day
Secondary outcomes:
measure: Change in BCVA.
timeFrame: 6 months
measure: Effect in anatomical changes.
timeFrame: 3 ±1 days after injection
measure: Safety.
timeFrame: Over 6 months.
measure: Retinal circulation integrity.
timeFrame: Month 1, 3, 6.
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Study officials:
affiliation: National Institute of Pharmacy
name: Attila Vajas, MD
role: PRINCIPAL_INVESTIGATOR
References: