Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 1, 2009
October 14, 2013
March 2009
September 2013   (final data collection date for primary outcome measure)
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
Efficacy measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks, postoperative retinal detachments and required endodiathermy. [ Time Frame: OP day. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931125 on ClinicalTrials.gov Archive Site
  • 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 )
  • Change in BCVA. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effect in anatomical changes. [ Time Frame: 7 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: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Retinopathy
  • Drug: ranibizumab and vitrectomy
    ranibizumab 10mg/ml intravitreal injection, 0,05 ml
    Other Name: Lucentis intravitreal injection.
  • Procedure: vitrectomy without preoperative ranibizumab
    sham intravitreal injection before vitrectomy surgery
  • Active Comparator: vitrectomy with ranibizumab
    Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
    Intervention: Drug: ranibizumab and vitrectomy
  • Placebo Comparator: vitrectomy without ranibizumab
    Patients receiving sham treatment before vitrectomy as a comparator arm
    Intervention: Procedure: vitrectomy without preoperative ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00931125
CRFB002AHU03T
Yes
Attila Vajas, University of Debrecen
Attila Vajas
Semmelweis University
Principal Investigator: Attila Vajas, MD National Institute of Pharmacy
University of Debrecen
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP