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

Sponsor
Attila Vajas
Study ID
NCT00931125
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 2, 2009
Start date
Mar 31, 2009
Status verified
Oct 2013
Primary completion
Sep 30, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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

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