INDEX Study
Research type
Research Study
Full title
The effect of ILUVIEN® in DMO patients with no or sub-optimal response to Dexamethasone intravitreal implant
IRAS ID
281058
Contact name
Maged Habib
Contact email
Sponsor organisation
South Tyneside and Sunderland NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Diabetic macular oedema (DMO) results from leaky vessels at the center of the retina at the back of the eye, causing fluid build-up and reduction in vision. Treatment of DMO includes laser, injections into the eye and steroid implants to dry the leaking fluid. there are 2 different types of steroid implants that can be used; (Ozurdex) and (Iluvien). In General, clinicians assume to link the response of both drugs to each other, hence if poor response is noted to one type of steroids (Ozurdex), the other implant (Iluvien) is not offered to patients with persistent DMO. There is no scientific basis for this assumption as both steroids are of different structural and chemical properties The study is designed to assess whether treatment with (Iluvien) implant would be beneficial in diabetic patients with DMO after poor or no response to a previous Ozurdex implant. if Visual and retinal structural benefit is noted in the study patients who are offered the Iluvien implant, this would allow to offer Iluvien to patients with persistent DMO who are otherwise denied treatment based on the current misconception.
Patients with chromic DMO who showed no or poor response to Ozurdex implant over the period of 6 months prior to the study will be eligible for inclusion. the study will take place in Sunderland Eye Infirmary. Patients will be monitored on 3 monthly basis following the implant as per the routine standard clinical care plans. The study primary and secondary outcomes will be measured and assessed at 12 months following the Iluvien implant.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0167
Date of REC Opinion
20 Jul 2020
REC opinion
Further Information Favourable Opinion