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Safety and Efficacy of Ranibizumab for Diabetic Macular Edema

NCT01982435 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-11-03

Study results available
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Summary

The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).

Conditions

Interventions

DRUG

Ranibizumab

Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.

DRUG

Ranibizumab

Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Justis Ehlers

    lead OTHER

Principal Investigators

  • Justis Ehlers, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-24
Primary Completion
2016-05-26
Completion
2016-05-26

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01982435 on ClinicalTrials.gov