Is it possible to use long acting steroid preparations such as the dexamethasone intravitreal implant Ozurdex to prevent a deterioration in vision in patients with diabetes undergoing cataract surgery in central Australia.

Intra-operative administration of dexamethasone intravitreal implants (Ozurdex) versus intravitreal Bevacizumab during cataract surgery for improving visual outcomes in the management of diabetic maculopathy in Central Australia.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000118505

Enrollment

Registered

2015-02-10

Start date

2015-08-10

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Diabetic macular edema (DME) is the most common cause of visual loss in people with diabetes. Regular injections with the anti-VEGF agent Bevacizumab remain the current standard of care for DME involving the fovea, but this regimen is impractical in central Australia. Limiting injections to 4 monthly with Ozurdex may be as effective as the currently used Bevacizumab injections.

Interventions

0.7mg intravitreal dexamethasone implant (Ozurdex) administered during cataract surgery. Followup will be offered monthly, with Ozurdex retreatment up to 4 monthly as clinically indicated. The overall intervention period for this trial will be 12 months. The implant does not need to be removed (it dissolves over time).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Adult patients treated by the Central Australian & Barkly Integrated Eye Health Service, who fit either of the following 2 treatment groups: A. Patients with active DME (defined as macular involving DR, with retinal thickening as assessed on clinical examination), or B. Patients with diabetic retinopathy without active DME - Participants must have significant lens opacity (more than grade 3 for any type of cataract) and scheduled to undergo cataract surgery at the time of enrolment into the study. - Participants must have reduced vision (BCVA impaired to at least the level of (6/9)) in the eye included for the study.

Exclusion criteria

- Prior intervention in the affected eye, including intravitreal anti-VEGF injections within the last 6 weeks, laser within the last 3 months, or Intravitreal triamcinolone within the last 6 months of time of surgery. - History of open-angle glaucoma or steroid induced IOP elevation that required IOP-lowering treatment, or, IOP greater than or equal to 25. - Eyes with concurrent ocular pathology other than DME causing visual loss. - Patients under the age of 18.

Outcome results