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Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO

NCT04619303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-11-09

No results posted yet for this study

Summary

DMO is the most common cause of visual loss in people with diabetes. Regular injections of bevacizumab (Avastin) given as frequently as every month remain the current standard of care for centre-involving DMO; however, this regimen is impractical for many Aboriginal patients. Using Ozurdex implants every 3-6 months could be as effective as the currently used Avastin injections. In order to address this real-world problem, this study seeks to investigate whether it is possible to safely use a long-acting steroid preparation such as the dexamethasone IVT implant (Ozurdex) to manage DMO in Aboriginal patients living in Western Australia.

Conditions

Interventions

DRUG

Dexamethasone intravitreal implant

Intravitreal injection of 0.7mg dexamethasone implant

DRUG

Bevacizumab Injectable Product

Invtravitreal injection of 1.25mg/0.05mL bevacizumab

Sponsors & Collaborators

  • Lions Outback Vision

    collaborator UNKNOWN

  • Allergan

    collaborator INDUSTRY

  • Lions Eye Institute, Perth, Western Australia

    lead OTHER

Principal Investigators

  • Angus Turner, FRANZCO · Lions Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-07
Primary Completion
2020-02-14
Completion
2020-02-14

Countries

  • Australia

Study Locations

More Related Trials

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 NCT04619303 on ClinicalTrials.gov