Back to resultsPanretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy (IRaHi)
Primary Purpose
Diabetic Retinopathy, Retinal Neovascularization
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ranibizumab
Panretinal Photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- High risk proliferative diabetic retinopathy
- Visual acuity ≥ 20/800
- No previous laser treatment for diabetic retinopathy
Exclusion Criteria:
- Previous pars plana vitrectomy
- Systemic thrombo-embolic events
- Uncontrolled systemic hypertension
- Conditions avoiding adequated documentation
- Previous eye surgery in the last 6 months before inclusion in the study
Sites / Locations
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRP plus ranibizumab
PRP
Arm Description
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Patients will only be submitted to panretinal photocoagulation
Outcomes
Primary Outcome Measures
Fluorescein leakage area (mm2)
Neovascularization area measured during fluorescein agiography middle phase
Secondary Outcome Measures
CMT
Macular thickness measured with Stratus OCT protocols
LogMAR BCVA
LogMAR best corrected visual acuity measured with ETDRS charts
Retina mid periphery visual field sensitivity change
Rod pathway integrity and oscillatory potential amplitudes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01102946
Brief Title
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy
Acronym
IRaHi
Official Title
Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Neovascularization
Keywords
proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP plus ranibizumab
Arm Type
Experimental
Arm Description
Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab
Arm Title
PRP
Arm Type
Active Comparator
Arm Description
Patients will only be submitted to panretinal photocoagulation
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab (Lucentis), intravitreal injections of 0.05ml
Intervention Type
Procedure
Intervention Name(s)
Panretinal Photocoagulation
Intervention Description
Panretinal photocoagulation with green laser according to ETDRS
Primary Outcome Measure Information:
Title
Fluorescein leakage area (mm2)
Description
Neovascularization area measured during fluorescein agiography middle phase
Time Frame
Week 48 after inclusion in the study
Secondary Outcome Measure Information:
Title
CMT
Description
Macular thickness measured with Stratus OCT protocols
Time Frame
Week 48 after inclusion in the study
Title
LogMAR BCVA
Description
LogMAR best corrected visual acuity measured with ETDRS charts
Time Frame
Week 48 after inclusion in the study
Title
Retina mid periphery visual field sensitivity change
Time Frame
Week 48 after inclusion in the study
Title
Rod pathway integrity and oscillatory potential amplitudes
Time Frame
Week 48 after inclusion in the study
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:
Age ≥ 18 years old
High risk proliferative diabetic retinopathy
Visual acuity ≥ 20/800
No previous laser treatment for diabetic retinopathy
Exclusion Criteria:
Previous pars plana vitrectomy
Systemic thrombo-embolic events
Uncontrolled systemic hypertension
Conditions avoiding adequated documentation
Previous eye surgery in the last 6 months before inclusion in the study
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
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21726427
Description
article on Pubmed
Learn more about this trial
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy
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