Ranibizumab for Diabetic Traction Retinal Detachment

Diabetic Retinopathy Clinical Trial

— RANITRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201161
• Other study ID #: RANITRA
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2010
• Last updated: September 13, 2010
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases

Intervention

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

Other:
• Sham injection
Simulation of intravitreal injection one week before pars plana vitrectomy

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of intraoperative intra-ocular bleeding	amount of intra-ocular bleeding that occurred during pars plana vitrectomy	one week	No
Secondary	visual acuity	ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy	12 weeks	No