Phase 4 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given their free, written, and informed consent to participate
• Adults (18 years of age or older)
• People with diabetic macular oedema (swelling in the central part of the retina) that has been treated but is still present after at least 2 years of treatment, where the swelling measures more than 300 microns in thickness and has caused a reduction in vision
• People whose best corrected vision (with glasses or lenses) scores 80 letters or fewer on a standard eye chart test (ETDRS)
• People who received at least one injection of dexamethasone (a steroid eye treatment) that showed a measurable benefit, with that injection given more than 5 months ago
• People who received at least one anti-VEGF injection (a type of eye injection used to reduce swelling) more than 3 months ago
• People who have had cataract surgery more than 6 months ago, with an artificial lens now in place
• People with diabetic macular oedema in one or both eyes (if both eyes are affected, the more severely affected eye would be the one treated in the trial)

Who may not be able to join:

• People who are not covered by national health insurance
• People who are under a legal protection order or guardianship arrangement
• People who are pregnant, in labour, or breastfeeding
• Adults who are unable to give informed consent
• People who have already taken part in this study
• People for whom attending all required follow-up appointments would not be possible (for example, due to relocation)
• People with a known allergy or sensitivity to the active ingredients or components of Ozurdex® or Iluvien®, or people with uveitis (eye inflammation) or severe asthma
• People with pre-existing uveitis, glaucoma, or an active or suspected infection in or around the eye — including certain viral conditions such as herpes of the cornea, chickenpox-related eye conditions, vaccinia, mycobacterial infections, or fungal infections
• People whose glycated haemoglobin (a measure of long-term blood sugar levels) is above 12%
• People who received an Iluvien (fluocinolone acetonide) injection in the eye being studied less than 24 months ago
• People with severe untreated diabetic retinopathy (damage to the blood vessels at the back of the eye) in the eye being studied
• People who had pan-retinal photocoagulation or focal laser treatment (types of laser eye treatment) in the eye being studied less than 3 months ago
• People with certain enlarged blood vessel abnormalities in the eye (capillary macro aneurysms) that could be treated with focal laser (confirm with trial site)
• People with elevated eye pressure above 21 mmHg that remains high despite using more than two different pressure-lowering medications
• People who have no natural or artificial lens in the eye, or who have a history of a torn lens capsule with certain types of implant fixation
• People who still have their natural lens in the eye being studied (i.e., people who have not had cataract surgery)

Important: Always verify eligibility with the trial site directly before applying.