Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01487629

Acronym

IBERA-DME

Enrollment

Registered

2011-12-07

Start date

2010-04-30

Completion date

2012-09-30

Last updated

2011-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Macular Edema

Keywords

Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab

Brief summary

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.

Interventions

DRUGBevacizumab

Bevacizumab, 1.5 mg, intravitreal, throughout the study

DRUGRanibizumab

Ranibizumab, 0.5 mg, intravitreal, throughout the study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Central subfield macular thickness (CSFT) change	Monthly from baseline to Week 48	Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)

Secondary

Measure	Time frame	Description
Best-corrected visual acuity change	Monthly from baseline to week 48	Best-corrected visual acuity using ETDRS charts

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026