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”

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.

Intervention(s) in this Clinical Trial

• Drug: ranibizumab and vitrectomy
  • ranibizumab 10mg/ml intravitreal injection, 0,05 ml
• Procedure: vitrectomy without preoperative ranibizumab
  • sham intravitreal injection before vitrectomy surgery

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: vitrectomy with ranibizumab
  • Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
• Placebo Comparator: vitrectomy without ranibizumab
  • Patients receiving sham treatment before vitrectomy as a comparator arm

Primary Measures

• Efficacy of preoperative intravitreal ranibizumab
  • Time Frame: OP day
    Safety Issue?: No

Secondary Measures

• Change in BCVA.
  • Time Frame: 6 months
    Safety Issue?: No
• Effect in anatomical changes.
  • Time Frame: 3 ±1 days after injection
    Safety Issue?: No
• Safety.
  • Time Frame: Over 6 months.
    Safety Issue?: Yes
• Retinal circulation integrity.
  • Time Frame: Month 1, 3, 6.
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Attila Vajas Other

Overall Clinical Trial Officials and Contacts

Attila Vajas, MD Principal Investigator National Institute of Pharmacy  

Overall Contact: Attila Vajas, MD +36-52-430-322 vajasa@gmail.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931125

Study ID Number: CRFB002AHU03T

ClinicalTrials.gov Identifier: NCT00931125

Health Authority: Hungary: National Institute of Pharmacy