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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: ranibizumab and vitrectomy
* Procedure: vitrectomy without preoperative ranibizumab


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitrectomy with ranibizumab<br>Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery | Drug: ranibizumab and vitrectomy<br>* ranibizumab 10mg/ml intravitreal injection, 0,05 ml<br>* Other names: Lucentis intravitreal injection.;|
| Placebo Comparator: vitrectomy without ranibizumab<br>Patients receiving sham treatment before vitrectomy as a comparator arm | Procedure: vitrectomy without preoperative ranibizumab<br>* sham intravitreal injection before vitrectomy surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of preoperative intravitreal ranibizumab | Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy | OP day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BCVA. |  | 6 months | 
| Effect in anatomical changes. |  | 3 ±1 days after injection | 
| Safety. |  | Over 6 months. | 
| Retinal circulation integrity. | Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography ) | Month 1, 3, 6. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe proliferative diabetic retinopathy