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Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema

NCT04018833 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-07-23

No results posted yet for this study

Summary

PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).

METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.

A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.

Conditions

Interventions

DRUG

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

DRUG

Aflibercept 40 MG/ML Intraocular Solution [EYLEA]

Sponsors & Collaborators

  • Bernardete Pessoa MD

    lead OTHER

Principal Investigators

  • João Melo-Beirão, MD, PhD · Centro Hospitalar do Porto

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2016-06-01
Completion
2016-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018833 on ClinicalTrials.gov