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Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema

NCT01572350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-02-15

No results posted yet for this study

Summary

This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.

Conditions

Interventions

OTHER

Grid laser

Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.

DRUG

Triamcinolone Acetonide

Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks

DRUG

Bevacizumab

Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks

Sponsors & Collaborators

  • Hospital Universitario de Canarias

    lead OTHER

Principal Investigators

  • Alicia Pareja, MD · Hospital Universitario de Canarias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Spain

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 NCT01572350 on ClinicalTrials.gov