Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— IBERA-DME  

Official title:

Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01487629
• Other study ID #: 13368/2010
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 2, 2011
• Last updated: December 9, 2011
• Start date: April 2010
• Est. completion date: September 2012

Study information

• Verified date: December 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

Drug:
• Bevacizumab
Bevacizumab, 1.5 mg, intravitreal, throughout the study
• Ranibizumab
Ranibizumab, 0.5 mg, intravitreal, throughout the study

Locations

Country	Name	City	State
Brazil	Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central subfield macular thickness (CSFT) change	Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT)	Monthly from baseline to Week 48	No
Secondary	Best-corrected visual acuity change	Best-corrected visual acuity using ETDRS charts	Monthly from baseline to week 48	No