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Ranibizumab for Diabetic Traction Retinal Detachment (RANITRA)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01201161
First received: September 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Retinal Detachment
 Drug: Ranibizumab
Other: Sham injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • amount of intraoperative intra-ocular bleeding [ Time Frame: one week ] [ Designated as safety issue: No ]
    amount of intra-ocular bleeding that occurred during pars plana vitrectomy


Secondary Outcome Measures:
  • visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy


Enrollment: 19
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RANI/PPV
Preoperative intravitreal ranibizumab and pars plana vitrectomy
 Drug: Ranibizumab
Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
Other Name: Lucentis
Placebo Comparator: PPV
Sham injection and pars plana vitrectomy
 Other: Sham injection
Simulation of intravitreal injection one week before pars plana vitrectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201161

Locations
Brazil
University of São Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rodrigo Jorge, MD, PhD University of São Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01201161     History of Changes
Other Study ID Numbers: RANITRA
Study First Received: September 13, 2010
Last Updated: September 13, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Diabetic Retinopathy
Retinal detachment
Vitreous Hemorrhage
Preoperative Ranibizumab
pars plana vitrectomy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Detachment
Retinal Diseases
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013