Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema (IBERA-DME)

University of Sao Paulo

Status and phase: Unknown; Phase 2

Conditions: Macular Edema; Diabetic Retinopathy

Treatments: Drug: Ranibizumab; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01487629

13368/2010

Details and patient eligibility

About

The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
• Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
• Central subfield macular thickness greater than 300 µm

Exclusion criteria

• Aphakia
• High-risk proliferative diabetic retinopathy
• Previous treatment for DME in the past three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53 participants in 2 patient groups

Bevacizumab

Experimental group

Description:

Treatment of macular edema with intravitreal Bevacizumab

Treatment:

Drug: Bevacizumab

Ranibizumab

Experimental group

Description:

Treatment of macular edema with intravitreal Ranibizumab

Treatment:

Drug: Ranibizumab