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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931125
Recruitment Status : Unknown
Verified October 2013 by Attila Vajas, University of Debrecen.
Recruitment status was:  Active, not recruiting
First Posted : July 2, 2009
Last Update Posted : October 16, 2013
Semmelweis University
Information provided by (Responsible Party):
Attila Vajas, University of Debrecen

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: ranibizumab and vitrectomy Procedure: vitrectomy without preoperative ranibizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2009
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
Drug: ranibizumab and vitrectomy
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
Other Name: Lucentis intravitreal injection.

Placebo Comparator: vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
Procedure: vitrectomy without preoperative ranibizumab
sham intravitreal injection before vitrectomy surgery

Primary Outcome Measures :
  1. Efficacy of preoperative intravitreal ranibizumab [ Time Frame: OP day ]
    Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy

Secondary Outcome Measures :
  1. Change in BCVA. [ Time Frame: 6 months ]
  2. Effect in anatomical changes. [ Time Frame: 3 ±1 days after injection ]
  3. Safety. [ Time Frame: Over 6 months. ]
  4. Retinal circulation integrity. [ Time Frame: Month 1, 3, 6. ]
    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 )

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931125

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University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
Debrecen, Hungary, H-4012
Sponsors and Collaborators
Attila Vajas
Semmelweis University
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Principal Investigator: Attila Vajas, MD National Institute of Pharmacy

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Responsible Party: Attila Vajas, MD, University of Debrecen Identifier: NCT00931125     History of Changes
Other Study ID Numbers: CRFB002AHU03T
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Attila Vajas, University of Debrecen:
Severe proliferative diabetic retinopathy

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents