Ranibizumab for Diabetic Traction Retinal Detachment

The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment

Sponsors

Lead Sponsor: University of Sao Paulo

Source 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.

Overall Status Completed
Start Date December 2008
Completion Date January 2010
Primary Completion Date January 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
amount of intraoperative intra-ocular bleeding one week
Secondary Outcome
Measure Time Frame
visual acuity 12 weeks
Enrollment 19
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ranibizumab

Description: Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

Arm Group Label: RANI/PPV

Other Name: Lucentis

Intervention Type: Other

Intervention Name: Sham injection

Description: Simulation of intravitreal injection one week before pars plana vitrectomy

Arm Group Label: PPV

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Rodrigo Jorge, MD, PhD Principal Investigator University of São Paulo
Location
Facility: University of São Paulo
Location Countries

Brazil

Verification Date

January 2010

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: RANI/PPV

Type: Experimental

Description: Preoperative intravitreal ranibizumab and pars plana vitrectomy

Label: PPV

Type: Placebo Comparator

Description: Sham injection and pars plana vitrectomy

Acronym RANITRA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov