Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy |
Drug: intravitreal injection of bevacizumab Procedure: panretinal photocoagulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study |
- 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
- Complications associated to each treatment
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Gerardo García-Aguirre, MD | +52 (55) 10841400 ext 1172 | retinamex@yahoo.com |
| Contact: Elizabeth Reyna-Castelán, MD | +52 (55)10841400 ext 1172 | retinamex@yahoo.com |
| Mexico | |
| Asociación para Evitar la Ceguera en México | Recruiting |
| Mexico City, D. F, Mexico, 04030 | |
| Contact: Yoko Burgoa +52 (55) 1084 1400 ext 1171 retinamex@yahoo.com | |
| Contact: Mariana Martinez, MD +52 (55) 1084 1400 ext 1171 retinamex@yahoo.com | |
| Principal Investigator: Gerardo García-Aguirre, MD | |
| Sub-Investigator: Hugo Quiroz-Mercado, MD | |
| Sub-Investigator: Veronica Kon-Jara, MD | |
| Sub-Investigator: Mitzy Torres, MD | |
| Sub-Investigator: Elizabeth Reyna-Castelan, MD | |
| Principal Investigator: | Gerardo García-Aguirre, MD | Asociación para Evitar la Ceguera en México |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00347698 History of Changes |
| Other Study ID Numbers: | APEC-007 |
| Study First Received: | June 30, 2006 |
| Last Updated: | June 30, 2006 |
| Health Authority: | Mexico: Ethics Committee Mexico: Ministry of Health |
Keywords provided by Asociación para Evitar la Ceguera en México:
|
diabetic retinopathy bevacizumab photocoagulation |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013