Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema

Asociación para Evitar la Ceguera en México

Status and phase: Withdrawn; Phase 3

Conditions: Diabetic Macular Edema; Diabetes Mellitus Type 2

Treatments: Drug: Intravitreal Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00417716

APEC-0011

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)