Comparing the effectiveness and safety of two treatments (OZURDEX® intravitreal implant versus Avastin®) for diabetic eye disease in adult Indigenous patients living in Western Australia.

A randomised active-controlled non-inferiority trial of OZURDEX® intravitreal implant versus Avastin® intravitreal injection in Indigenous patients with or at risk of diabetic macular oedema, at the time of or following cataract surgery. (The OASIS Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000202268

Acronym

OASIS

Enrollment

Registered

2018-02-07

Start date

2017-02-07

Completion date

2019-04-29

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

DMO is the most common cause of visual loss in people with diabetes. Regular injections with bevacizumab (Avastin), given as frequently as every month, remain the current standard of care for centre-involving DMO, but this regimen is impractical for many Indigenous patients. Limiting injections to 3-6 monthly with Ozurdex may be as effective as the currently used Avastin injections. The specific aim of the study is therefore to test the following hypothesis: 1. Ozurdex® is a safe and non-inferior treatment to Avastin® when administered during or following cataract surgery in Indigenous patients with/at risk of DMO. 2. Ozurdex ® requires fewer injections when compared with Avastin® in Indigenous patients with/at risk of DMO.

Interventions

0.7mg intravitreal dexamethasone implant (Ozurdex) administered by a consultant ophthalmologist, or an ophthalmology fellow under consultant supervision, in operating theatres at the time of cataract surgery for phakic participants. The injection will be performed after implantation of the intraocular lens for patients undergoing cataract surgery. The case duration is expected to be approximately 20 minutes in most cases. For pseudophakic participants, injections will be performed in outpatient treatment facilities by the same clinical staff as above. The treatment duration is expected to be 5 minutes for most pseudophakic participants. Followup will be offered monthly with retreatment as clinically indicated. The overall intervention period for this trial will be 12 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Self-identifying Indigenous Australian. • Adult aged 18 years and over. • Diagnosis of diabetes mellitus (type 1 or 2). • Best-corrected visual acuity (BCVA) of at best 6/9 to 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 diabetic retinopathy with: A. Active DMO (phakic or pseudophakic patients): Centre-involving/threatening DMO, as defined by clinical examination and OCT scan findings. B. At risk of DMO (phakic patients only): Assessed as being at risk of post-operative DMO based on clinical examination, OCT scan findings and investigator discretion.

Exclusion criteria

• Intervention in the study eye including: - Intravitreal anti-VEGF injections within the last 6 weeks; - Macular laser within the last 4 months; - Intravitreal triamcinolone or triescence within the last 6 months; of time of first trial treatment. • History of open-angle glaucoma or steroid induced IOP elevation that required IOP- lowering treatment or, IOP =25 (Goldmann applanation) on 2 consecutive clinic visits. • Eyes with concurrent ocular pathology other than DMO causing visual loss. • 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 anterior chamber intraocular lens and rupture of the posterior lens capsule. - Known angina, myocardial infarction, TIA or CVA in last 3 months. - Known hypersensitivity to any components of these products

Outcome results