Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO

Sponsor
Lions Eye Institute, Perth, Western Australia
Study ID
NCT04619303
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone intravitreal implant — DRUG
    Intravitreal injection of 0.7mg dexamethasone implant
  • Bevacizumab Injectable Product — DRUG
    Invtravitreal injection of 1.25mg/0.05mL bevacizumab

Study Details

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.

Key Dates

First listed
Nov 6, 2020
Start date
Feb 7, 2017
Status verified
Nov 2020
Primary completion
Feb 14, 2020
Completion
Feb 14, 2020

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dexamethasone Implant
    Receive 0.7mg dexamethasone implant (Ozurdex) at baseline visit. Monthly review with repeat administration of intravitreal treatment every three months for DMO and laser as clinically indicated.
  • Active Comparator: Bevacizumab
    Receive 1.25mg/0.05ml bevacizumab (Avastin) at baseline visit. Monthly review with repeat administration of intravitreal treatment every one month for DMO and laser as clinically indicated.

Primary Outcome Measure

Difference in best corrected visual acuity change between treatment arms [ Time Frame: 12 months ]

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