Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO

• Status: Completed
• Trial end date: 2020-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lions Eye Institute, Perth, Western Australia
• Collaborators: Allergan; Lions Outback Vision
• Treatments: Bevacizumab; Dexamethasone

Criteria

Inclusion criteria:

• Self-identifying as Aboriginal Australian or Torres Strait Islander

• Adults aged 18 years and over

• Diagnosis of DM (type 1 or type 2)

• BCVA of at best 0.2 LogMAR (20/32) 6/9 in the study eye

• Pseudophakic, or phakic with significant lens opacity and scheduled to undergo cataract surgery at the time of enrolment

• Presence of any grade of DR with centre-involving DMO, as defined by clinical examination and OCT scan findings

• Active DMO: Centre-involving/threatening DMO, as defined by clinical examination and OCT scan findings.

• At risk of DMO: Patients scheduled for cataract surgery with non-centre involving DMO who are assessed as being at risk of post-operative centre-involving DMO based on clinical examination, OCT scan findings, and Investigator discretion.

Exclusion criteria:

• Intervention: Previous treatment in the study eye including at the time of the first trial treatment with:

• IVT anti-VEGF injections within the last six weeks;

• Macular laser treatment within the last four months;

• IVT triamcinolone or triescence within the last six months; at the time of the first trial treatment.

• History of open-angle glaucoma or steroid-induced IOP elevation that required IOP-lowering treatment or, IOP ≥25 (Goldmann applanation) on two consecutive clinic visits.

• Eyes with concurrent ocular pathology other than DMO, or a cataract-causing visual loss, including macular ischaemia as determined by clinical examination and FFA imaging.

• Women who are breastfeeding, confirmed as pregnant or planning on becoming pregnant in the next 6-12 months.

• Participants for whom Ozurdex or Avastin treatment are contraindicated as per product information:

• Active or suspected ocular/periocular infections, including most viral diseases of the cornea and conjunctiva, active epithelia herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

• Aphakic eyes with rupture of the posterior lens capsule.

• Eyes with an anterior chamber intraocular lens and rupture of the posterior lens capsule.

• Known angina, myocardial infarction, TIA or CVA in the last three months.

• Known hypersensitivity to any components of these products.