Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
Primary Purpose
Diabetic Retinopathy
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
intravitreal injection of bevacizumab
panretinal photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, bevacizumab, photocoagulation
Eligibility Criteria
Inclusion Criteria: symmetric proliferative diabetic retinopathy without high risk characteristics age 18 years or older patient consent Exclusion Criteria: heart attack or cerebrovascular attack only eye retinal detachment vitreous haemorrhage previous treatment for diabetic retinopathy media opacities that preclude visualization of the fundus pregnancy inability to understands the implications of the protocol
Sites / Locations
- Asociación para Evitar la Ceguera en MéxicoRecruiting
Outcomes
Primary Outcome Measures
Best corrected visual acuity at six months and one year
Macular thickness measured by OCT at six months and one year
Median deviation in visual fields at one year
Score on a patient satisfaction scale at six months and one year
Secondary Outcome Measures
Complications associated to each treatment
Full Information
NCT ID
NCT00347698
First Posted
June 30, 2006
Last Updated
June 30, 2006
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00347698
Brief Title
Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
Official Title
Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.
Detailed Description
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, bevacizumab, photocoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of bevacizumab
Intervention Type
Procedure
Intervention Name(s)
panretinal photocoagulation
Primary Outcome Measure Information:
Title
Best corrected visual acuity at six months and one year
Title
Macular thickness measured by OCT at six months and one year
Title
Median deviation in visual fields at one year
Title
Score on a patient satisfaction scale at six months and one year
Secondary Outcome Measure Information:
Title
Complications associated to each treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symmetric proliferative diabetic retinopathy without high risk characteristics
age 18 years or older
patient consent
Exclusion Criteria:
heart attack or cerebrovascular attack
only eye
retinal detachment
vitreous haemorrhage
previous treatment for diabetic retinopathy
media opacities that preclude visualization of the fundus
pregnancy
inability to understands the implications of the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo García-Aguirre, MD
Phone
+52 (55) 10841400
Ext
1172
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Reyna-Castelán, MD
Phone
+52 (55)10841400
Ext
1172
Email
retinamex@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo García-Aguirre, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación para Evitar la Ceguera en México
City
Mexico City
State/Province
D. F
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoko Burgoa
Phone
+52 (55) 1084 1400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mariana Martinez, MD
Phone
+52 (55) 1084 1400
Ext
1171
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Gerardo García-Aguirre, MD
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
First Name & Middle Initial & Last Name & Degree
Veronica Kon-Jara, MD
First Name & Middle Initial & Last Name & Degree
Mitzy Torres, MD
First Name & Middle Initial & Last Name & Degree
Elizabeth Reyna-Castelan, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
3658348
Citation
Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987 Jul;94(7):761-74. doi: 10.1016/s0161-6420(87)33527-4.
Results Reference
background
PubMed Identifier
1171677
Citation
Frank RN. Visual fields and electroretinography following extensive photocoagulation. Arch Ophthalmol. 1975 Aug;93(8):591-8. doi: 10.1001/archopht.1975.01010020575004.
Results Reference
background
PubMed Identifier
16458724
Citation
Salti H. Visual dysfunction after panretinal photocoagulation in patients with severe diabetic retinopathy and good vision. Am J Ophthalmol. 2006 Feb;141(2):422; author reply 422-3. doi: 10.1016/j.ajo.2005.10.040. No abstract available.
Results Reference
background
PubMed Identifier
12597922
Citation
Witmer AN, Vrensen GF, Van Noorden CJ, Schlingemann RO. Vascular endothelial growth factors and angiogenesis in eye disease. Prog Retin Eye Res. 2003 Jan;22(1):1-29. doi: 10.1016/s1350-9462(02)00043-5.
Results Reference
background
PubMed Identifier
9377574
Citation
Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, Winkler M, Ferrara N. Humanization of an anti-vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res. 1997 Oct 15;57(20):4593-9.
Results Reference
background
PubMed Identifier
16508426
Citation
Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.
Results Reference
background
PubMed Identifier
16508438
Citation
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006 Mar;26(3):352-4. doi: 10.1097/00006982-200603000-00016. No abstract available.
Results Reference
background
PubMed Identifier
16508427
Citation
Iturralde D, Spaide RF, Meyerle CB, Klancnik JM, Yannuzzi LA, Fisher YL, Sorenson J, Slakter JS, Freund KB, Cooney M, Fine HF. Intravitreal bevacizumab (Avastin) treatment of macular edema in central retinal vein occlusion: a short-term study. Retina. 2006 Mar;26(3):279-84. doi: 10.1097/00006982-200603000-00005.
Results Reference
background
PubMed Identifier
16156152
Citation
Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.
Results Reference
background
PubMed Identifier
16156153
Citation
Rosenfeld PJ, Fung AE, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for macular edema from central retinal vein occlusion. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):336-9.
Results Reference
background
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Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
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