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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Attila Vajas

Current Primary Outcome: Efficacy of preoperative intravitreal ranibizumab [ Time Frame: OP day ]

Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy


Original Primary Outcome: Efficacy measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks, postoperative retinal detachments and required endodiathermy. [ Time Frame: OP day. ]

Current Secondary Outcome:

  • Change in BCVA. [ Time Frame: 6 months ]
  • Effect in anatomical changes. [ Time Frame: 3 ±1 days after injection ]
  • Safety. [ Time Frame: Over 6 months. ]
  • 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 )


Original Secondary Outcome:

  • Change in BCVA. [ Time Frame: 12 months ]
  • Effect in anatomical changes. [ Time Frame: 7 days after injection ]
  • Safety. [ Time Frame: Over 6 months. ]
  • Retinal circulation integrity. [ Time Frame: Month 1, 3, 6. ]


Information By: University of Debrecen

Dates:
Date Received: July 1, 2009
Date Started: March 2009
Date Completion: December 2013
Last Updated: October 14, 2013
Last Verified: October 2013