RecruitingPhase 2Phase 3ACTRN12615000118505

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.


Sponsor

Alice Springs Hospital

Enrollment

40 participants

Start Date

Aug 10, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a long-acting steroid eye injection called Ozurdex can help protect the eyesight of people with diabetes who are having cataract surgery in Central Australia. Diabetic macular edema — swelling at the back of the eye — is a common cause of vision loss in people with diabetes and can get worse around the time of surgery. You may be eligible if: - You are 18 years of age or older - You have diabetes and either active diabetic macular edema or diabetic retinopathy - You have a significant cataract (grade 3 or higher) and are scheduled for cataract surgery - Your vision in the affected eye is reduced to at least the level of 6/9 - You are a patient of the Central Australian and Barkly Integrated Eye Health Service You may NOT be eligible if: - You have had an eye injection within the last 6 weeks, laser eye treatment in the last 3 months, or a steroid injection in the eye within the last 6 months - You have open-angle glaucoma or a history of high eye pressure requiring treatment - You have another eye condition besides diabetic eye disease causing your vision loss - You are under 18 years old Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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).


Locations(2)

Alice Springs Hospital - Alice Springs

NT,SA, Australia

Flinders Medical Centre - Bedford Park

NT,SA, Australia

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ACTRN12615000118505


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