Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
Information source: Asociación para Evitar la Ceguera en México
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diffuse Diabetic Macular Edema
Intervention: Triamcinolone Acetonide and Bevacizumab (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Asociación para Evitar la Ceguera en México Official(s) and/or principal investigator(s):
Maximiliano Gordon, MD, Principal Investigator, Affiliation: APEC
Overall contact:
Maximiliano Gordon, MD, Phone: 10841400, Ext: 1171, 1172, Email: retinamex@yahoo.com
Summary
Diabetic macular edema is the most common cause of visual loss among patients with diabetic
retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of
diabetic macular edema. Previous report showed a limited improvement in visual acuity and
macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal
injection has been proven be effective in the treatment of diabetic macular edema, in recent
publications. The purpose of this study is to evaluate whether vitrectomy with and without
intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and
macular thickness in patients with diabetic macular edema.
Clinical Details
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 20 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diffuse diabetic macular edema
- Non proliferative diabetic retinopathy
- No VPP previa
- No previous treament with laser, Triamcinolone acetonide, and Bevacizumab
Exclusion Criteria:
- Proliferative diabetic retinopathy
- Previous pars plana vitrectomy
- Previous treatment with diabetic macular edema
- Focal macular edema
- Macular Ischemia
Locations and Contacts
Maximiliano Gordon, MD, Phone: 10841400, Ext: 1171, 1172, Email: retinamex@yahoo.com
Asociacion Para Evitar la Ceguera en Mexico, Mexico D.F., D.F. 04030, Mexico; Recruiting
Maximiliano Gordon, MD, Phone: 10841400, Ext: 1171, 1172, Email: retinamex@yahoo.com
Additional Information
Last updated: January 23, 2008
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