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Sponsored by: |
Asociación para Evitar la Ceguera en México |
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Information provided by: | Asociación para Evitar la Ceguera en México |
ClinicalTrials.gov Identifier: | NCT00571142 |
To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.
Condition | Intervention | Phase |
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* Diffuse Diabetic Macular Edema |
Procedure: Bevacizumab + Pars plana vitrectomy Procedure: Bevacizumab + pars plana vitrectomy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study) |
Estimated Enrollment: | 20 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Renal disease
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Procedure: Bevacizumab + Pars plana vitrectomy
2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
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2: Active Comparator
Without renal disease
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Procedure: Bevacizumab + pars plana vitrectomy
2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy
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Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Veronica Kon-Jara, MD | 5215537291895 | veronicakon@yahoo.com |
Contact: Antonieta Burgoa | 10841400 ext 1171 | retinamex@yahoo.com |
Mexico | |
Asociacion para Evitar la Ceguera en Mexico I.A.P. | Recruiting |
Mexico, Mexico, 04030 | |
Sub-Investigator: Ma Ana Martinez-Castellanos, MD | |
Sub-Investigator: Oscar Alvarez-Verduzco, MD | |
Sub-Investigator: Jose Luis Guerrero-Naranjo, MD | |
Sub-Investigator: Hugo Quiroz-Mercado, MD |
Principal Investigator: | Veronica Kon-Jara, MD | Asociacion para Evitar la Ceguera en Mexico |
Responsible Party: | Asociacion para Evitar la Ceguera en Mexico I.A.P. ( Veronica Kon-Jara MD ) |
Study ID Numbers: | APEC-ret |
Study First Received: | December 7, 2007 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00571142 |
Health Authority: | Mexico: Subsecretary of Ministry of Health, Mexico city |
edema retinal thickness diabetic retinopathy |
Signs and Symptoms Macular Edema Diabetic Retinopathy Eye Diseases Temazepam Retinal Degeneration |
Macular Degeneration Edema Bevacizumab Retinal Diseases Retinal degeneration |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |