Ranibizumab for Diabetic Traction Retinal Detachment

Sponsor
University of Sao Paulo
Study ID
NCT01201161
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
  • Sham injection — OTHER
    Simulation of intravitreal injection one week before pars plana vitrectomy

Study Details

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Key Dates

First listed
Sep 14, 2010
Start date
Dec 31, 2008
Status verified
Jan 2010
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RANI/PPV
    Preoperative intravitreal ranibizumab and pars plana vitrectomy
  • Placebo Comparator: PPV
    Sham injection and pars plana vitrectomy

Primary Outcome Measure

amount of intraoperative intra-ocular bleeding [ Time Frame: one week ]

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