Aflibercept for Diabetic Macular Oedema: Outcomes Using a Treat and Extend Protocol

Phase 4

Recruiting

• Conditions: Diabetic Macular Oedema; Metabolic and Endocrine - Diabetes; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619000963123
• Lead Sponsor: The Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-08
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult patients 18 years or over with a diagnosis of type 1 or 2 diabetes mellitus.
2. Treatment naïve eyes with evidence of centre involving DMO on FFA and OCT.
3. BCVA equal to between 73 (6/9.5) and 24 (6/95) ETDRS letters inclusive.
4. Definite retinal thickening on clinical examination due to DMO involving the central macula.
5. Media clarity, pupillary dilatation and individual cooperation to allow adequate fundus photographs.
6. Central subfield thickness on Heidelberg Spectralis of equal to or greater than 300um.

Exclusion Criteria

1. Previous treatment with an anti-VEGF agent or intravitreal triamcinolone acetate.
2. Active proliferative diabetic retinopathy in the study eye.
3. Neovascularisation of the iris or angle.
4. Previous macular laser or pan retinal photocoagulation treatment within the last 4 months.
5. Maculopathy due to another cause.
6. History of retinal detachment or surgery for retinal detachment.
7. Previous vitrectomy.
8. Any existing ocular disorder that would prevent improvement in visual acuity such as macular ischaemia, dense foveal lipid exudates, epiretinal membrane or macular hole, or any significant media opacities such as cataract, which, in an otherwise healthy eye would reduce the vision to less than 6/12.
9. Aphakia
10. YAG laser use in the 2 months prior to treatment.
11. Any active periocular or intraocular infection or severe blepharitis.
12. Any active intraocular inflammation or uncontrolled intraocular pressure.
13. Any known hypersensitivity to aflibercept or any of the excipients in aflibercept.
14. Any arterial thromboembolic event including stoke, myocardial infarction or vascular embolism in the last 3 months.
15. Any positive pregnancy or current breast feeding or patients who are planning for a pregnancy or likely to be breast feeding over the next 24 months.
16. Chronic renal failure requiring dialysis or transplant.
17. Unstable blood pressure >180/110, cardiovascular disease or glycaemic control (BSL more often than not over 20mmol/L).
18. Participation within another trial of an unapproved drug within 30 days of entry into this trial.
19. Myocardial infarct, other acute cardiovascular event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 4 months prior to entry into the study.
20. Systemic anti-VEGF or pro-VEGF treatment within four months prior to study entry or anticipated use of the drug during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified