Combined Ranibizumab and Iluvien for Diabetic Macular Oedema

• Status: Withdrawn
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial investigated whether adding Iluvien sustained release steroid intravitreal eye implant at the beginning of regular anti-VEGF (anti Vascular Endothelial Growth Factor) intravitreal eye injection treatment for diabetic macular oedema would improve disease stability and reduce the need for regular anti-VEGF intravitreal eye injections over first two years. Diabetic macular oedema, accumulation of microscopic fluid at the back of the eye, is a major cause of poor vision in patients with diabetes.

This is a double mask randomized control multisite trial, to be conducted at 10 NHS hospital eye clinics in England.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Fluocinolone Acetonide; Ranibizumab

Criteria

Inclusion Criteria:

General

1. Willingness and the ability to provide informed consent.

2. Ability and willingness to undertake all scheduled visits, assessment and treatment.

3. Age 18 years or above.

4. Documented diagnosis of diabetes mellitus (Type I or Type II) as per WHO (World Health Organization) criteria.

5. Current regular use of oral anti-hyperglycaemia or insulin therapy.

6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the study duration of 24 months.

Ocular

1. Macular thickening due to Diabetic Macular Oedema (DMO) involving the centre of fovea as measured by Spectral Domain OCT with CRT of at least 400 microns.

2. DMO confirmed by clinical examination and fundus fluorescein angiography.

3. BCVA between 73 to 25 letters inclusive (Snellen equivalent to 6/12 to 6/96) as measured using ETDRS protocol at 4 meters.

4. Pseudophakia in the study eye.

5. Adequate ocular media clarity and pupillary dilatation allowing for posterior segment examination and OCT scanning.

Exclusion Criteria:

General

1. Cerebral vascular accident, transient ischaemic attack or myocardial infarction within 3 months prior to day 1 (baseline).

2. Pregnancy or breastfeeding, or intention to become pregnant during the study.

3. Participation in an investigational trial involving treatment with any drug or devices within 3 months prior to day 1 (baseline) and must not be enrolled in another investigational trial during their participation in this trial.

4. Systemic anti-VEGF-base therapies within 3 months prior to day 1 (baseline).

Ocular

1. History of prior intravitreal anti-VEGF therapy or steroid implant in the study eye.

2. History of proliferative diabetic retinopathy.

3. History of rubeosis or current rubeosis.

4. History of neovascularization, tractional retinal detachment, retinal vein occlusion, or significant pre-retinal fibrosis distorting the macular architecture.

5. History of retinal detachment or macular hole stage 3 or above.

6. History of vitreoretinal surgery.

7. Aphakia.

8. History of glaucoma or uncontrolled ocular hypertension.

9. Active or suspected ocular or periocular infection or inflammation, including viral diseases of the cornea, conjunctiva and retina, such as active epithelial herpes simplex keratitis (dendritic keratitis), varicella, mycobacterial infections, and fungal diseases.

10. Panretinal Photocoagulation (PRP) laser treatment within 3 months prior to day 1.

11. Macular laser (focal or grid) within 3 months prior to day 1.

12. YAG (yttrium aluminium garnet) laser capsulotomy laser within 3 months prior to day 1.

13. Any periocular steroid treatment within 6 months prior to day 1.

14. Cataract operation within 3 months prior to day 1.