Ranibizumab for Diabetic Traction Retinal Detachment
Phase 2
Completed
- Conditions
- Diabetic RetinopathyRetinal Detachment
- Interventions
- Other: Sham injection
- Registration Number
- NCT01201161
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Exclusion Criteria
- Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- Previous intra-ocular surgery other than cataract surgery
- Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- Prothrombin time, partial thromboplastin time or platelet count without normal limits
- History of previous thromboembolic events
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RANI/PPV Ranibizumab Preoperative intravitreal ranibizumab and pars plana vitrectomy PPV Sham injection Sham injection and pars plana vitrectomy
- Primary Outcome Measures
Name Time Method amount of intraoperative intra-ocular bleeding one week amount of intra-ocular bleeding that occurred during pars plana vitrectomy
- Secondary Outcome Measures
Name Time Method visual acuity 12 weeks ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy
Trial Locations
- Locations (1)
University of São Paulo
🇧🇷Ribeirao Preto, Sao Paulo, Brazil