- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347698
Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
June 30, 2006 updated by: Asociación para Evitar la Ceguera en México
Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gerardo García-Aguirre, MD
- Phone Number: 1172 +52 (55) 10841400
- Email: retinamex@yahoo.com
Study Contact Backup
- Name: Elizabeth Reyna-Castelán, MD
- Phone Number: 1172 +52 (55)10841400
- Email: retinamex@yahoo.com
Study Locations
-
-
D. F
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Mexico City, D. F, Mexico, 04030
- Recruiting
- Asociación Para Evitar la Ceguera en México
-
Contact:
- Yoko Burgoa
- Phone Number: 1171 +52 (55) 1084 1400
- Email: retinamex@yahoo.com
-
Sub-Investigator:
- Elizabeth Reyna-Castelan, MD
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Sub-Investigator:
- Veronica Kon-Jara, MD
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Contact:
- Mariana Martinez, MD
- Phone Number: 1171 +52 (55) 1084 1400
- Email: retinamex@yahoo.com
-
Principal Investigator:
- Gerardo García-Aguirre, MD
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Sub-Investigator:
- Mitzy Torres, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Complications associated to each treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gerardo García-Aguirre, MD, Asociación Para Evitar la Ceguera en México
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Frank RN. Visual fields and electroretinography following extensive photocoagulation. Arch Ophthalmol. 1975 Aug;93(8):591-8. doi: 10.1001/archopht.1975.01010020575004.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
August 1, 2007
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
July 4, 2006
Last Update Submitted That Met QC Criteria
June 30, 2006
Last Verified
June 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- APEC-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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