Ranibizumab for Diabetic Traction Retinal Detachment (RANITRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01201161
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Retinal Detachment Drug: Ranibizumab Other: Sham injection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : December 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. amount of intraoperative intra-ocular bleeding [ Time Frame: one week ]
    amount of intra-ocular bleeding that occurred during pars plana vitrectomy

Secondary Outcome Measures :
  1. visual acuity [ Time Frame: 12 weeks ]
    ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01201161

University of São Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Rodrigo Jorge, MD, PhD University of São Paulo Identifier: NCT01201161     History of Changes
Other Study ID Numbers: RANITRA
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Dissociative Disorders
Retinal Detachment
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action