Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Condition(s) targeted: Diabetes Mellitus Type 2; Diabetic Macular Edema

Intervention: Intravitreal Bevacizumab (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Asociación para Evitar la Ceguera en México

Official(s) and/or principal investigator(s):
Adriana Solís-Vivanco, MD, Principal Investigator, Affiliation: Asociación para Evitar la Ceguera en México
Jans Fromow-Guerra, MD PhD, Study Chair, Affiliation: Asociación para Evitar la Ceguera en México
Elizabeth Reyna-Castelán, Study Chair, Affiliation: Asociación para Evitar la Ceguera en México
Juan M Jiménez-Sierra, MD, Study Chair, Affiliation: Asociación para Evitar la Ceguera en México
Myriam Hernández-Rojas, MD, Study Chair, Affiliation: Asociación para Evitar la Ceguera en México
Griselda Alvarez-Rivera, MD, Study Chair, Affiliation: Asociación para Evitar la Ceguera en México
Hugo Quiroz-Mercado, MD, Study Director, Affiliation: Asociación para Evitar la Ceguera en México

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

Official title: The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

BCVA

Fluorescein Angiography

Optical Coherence Tomography

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.

Minimum age: 45 Years. Gender(s): Both.

Criteria:

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)

Asociación para Evitar la Ceguera en México, Mexico city, Distrito Federal 04030, Mexico

Starting date: September 2005
Ending date: May 2006
Last updated: January 3, 2007