This trial is active, not recruiting.

Conditions diabetes mellitus type 2, diabetic macular edema
Treatment intravitreal bevacizumab
Phase phase 3
Sponsor Asociación para Evitar la Ceguera en México
Start date September 2005
End date May 2006
Trial size 45 participants
Trial identifier NCT00417716, APEC-0011


Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

time frame:
Fluorescein Angiography
time frame:
Optical Coherence Tomography
time frame:

Eligibility Criteria

Male or female participants at least 45 years old.

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)

Additional Information

Official title The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Principal investigator Adriana Solís-Vivanco, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Asociación para Evitar la Ceguera en México.