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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Semmelweis University
Information provided by (Responsible Party):
Attila Vajas, University of Debrecen
ClinicalTrials.gov Identifier:
NCT00931125
First received: July 1, 2009
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Drug: ranibizumab and vitrectomy
Procedure: vitrectomy without preoperative ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Debrecen:

Primary Outcome Measures:
  • Efficacy of preoperative intravitreal ranibizumab [ Time Frame: OP day ] [ Designated as safety issue: No ]
    Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy


Secondary Outcome Measures:
  • Change in BCVA. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Effect in anatomical changes. [ Time Frame: 3 ±1 days after injection ] [ Designated as safety issue: No ]
  • Safety. [ Time Frame: Over 6 months. ] [ Designated as safety issue: Yes ]
  • Retinal circulation integrity. [ Time Frame: Month 1, 3, 6. ] [ Designated as safety issue: Yes ]
    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 )


Estimated Enrollment: 70
Study Start Date: March 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931125

Locations
Hungary
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
Investigators
Principal Investigator: Attila Vajas, MD National Institute of Pharmacy
  More Information

No publications provided

Responsible Party: Attila Vajas, MD, University of Debrecen
ClinicalTrials.gov Identifier: NCT00931125     History of Changes
Other Study ID Numbers: CRFB002AHU03T
Study First Received: July 1, 2009
Last Updated: October 14, 2013
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by University of Debrecen:
Severe proliferative diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014