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Ranibizumab for Diabetic Traction Retinal Detachment (RANITRA)

Primary Purpose

Diabetic Retinopathy, Retinal Detachment

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ranibizumab
Sham injection
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RANI/PPV

PPV

Arm Description

Preoperative intravitreal ranibizumab and pars plana vitrectomy

Sham injection and pars plana vitrectomy

Outcomes

Primary Outcome Measures

amount of intraoperative intra-ocular bleeding
amount of intra-ocular bleeding that occurred during pars plana vitrectomy

Secondary Outcome Measures

visual acuity
ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy

Full Information

First Posted
September 13, 2010
Last Updated
September 13, 2010
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01201161
Brief Title
Ranibizumab for Diabetic Traction Retinal Detachment
Acronym
RANITRA
Official Title
The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Detachment
Keywords
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RANI/PPV
Arm Type
Experimental
Arm Description
Preoperative intravitreal ranibizumab and pars plana vitrectomy
Arm Title
PPV
Arm Type
Placebo Comparator
Arm Description
Sham injection and pars plana vitrectomy
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Simulation of intravitreal injection one week before pars plana vitrectomy
Primary Outcome Measure Information:
Title
amount of intraoperative intra-ocular bleeding
Description
amount of intra-ocular bleeding that occurred during pars plana vitrectomy
Time Frame
one week
Secondary Outcome Measure Information:
Title
visual acuity
Description
ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Jorge, MD, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil

12. IPD Sharing Statement

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Ranibizumab for Diabetic Traction Retinal Detachment

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