Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Phase 3
Withdrawn
- Conditions
- Diabetic Macular EdemaDiabetes Mellitus Type 2
- Registration Number
- NCT00417716
- Lead Sponsor
- Asociación para Evitar la Ceguera en México
- Brief Summary
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema
- Detailed Description
A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Type 2 diabetes
- Macular edema involving the center of the macula demonstrated on OCT
- Clear ocular media
- Untreated patients
- Older than 45 years
- BCVA of the fellow eye at least 20/100
Exclusion Criteria
- Renal diabetic disease, uncontrolled hypertension or stroke history
- Other ocular disease
- Ocular surgery excepting uncomplicated phacoemulsification
- History of photocoagulation (panretinal or focal)
- History of another intravitreal treatment (like triamcinolone)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method BCVA Fluorescein Angiography Optical Coherence Tomography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asociación para Evitar la Ceguera en México
🇲🇽Mexico city, Distrito Federal, Mexico