Phase 2 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 diabetic macular edema (a swelling in the central part of the retina caused by diabetes) that has been confirmed by a specific type of eye scan, with swelling measuring at a certain level or above.
• People whose eyes are clear enough, and whose pupils can be dilated enough, to allow good-quality photographs of the back of the eye to be taken.
• People who have been diagnosed with type 1 or type 2 diabetes and are receiving regular treatment for it, with a blood sugar control measurement (HbA1c) below 12%.
• People who are willing and able to understand what the study involves and the risks that come with it.
• People who have read and signed a consent form before any study procedures begin.
• People aged 18 or older (or above the legal adult age in their country) at the time of signing the consent form.
• Both men and women are eligible; women who could become pregnant must be willing to use highly effective contraception, and men must be willing to use a condom or abstain from sex to prevent a partner becoming pregnant.
• Additional criteria may also apply (confirm with trial site).

Who may not be able to join:

• People who have only one eye that works, even if that eye would otherwise meet the study requirements — the other eye must have enough vision to support the person's daily life, in the treating doctor's judgement.
• People whose study eye shows signs of an advanced stage of diabetic eye disease where new, abnormal blood vessels are actively growing on the retina (confirm with trial site for borderline cases).
• People whose study eye shows signs of active abnormal blood vessel growth in certain areas of the retina, as confirmed by specialist eye imaging and a central review centre — though people with such growth only in outer areas of the retina may still be considered if the treating doctor judges it does not need urgent treatment.
• People whose study eye shows active abnormal blood vessel growth on the iris or in the drainage angle of the eye (very small iris tufts are not a reason for exclusion).
• People whose study eye has additional eye conditions that could affect their ability to take part, including: uncontrolled pressure inside the eye above a certain level even with treatment; a history of very high short-sightedness in the study eye; certain abnormalities at the front of the eye or in the gel of the eye that would make it hard to detect eye inflammation or other problems; or other eye conditions that the treating doctor judges could interfere with the study results.
• People who have previously received gene therapy or cell therapy in the eye.
• People who have used corticosteroid medications (either in the eye or anywhere in the body) within one month before the screening visit.
• People who are missing the natural lens of the eye entirely, or who are missing the membrane that holds the lens in place — though people who have had a specific laser procedure on that membrane more than two months before the study start date may be eligible (confirm with trial site).
• Additional exclusion criteria may also apply (confirm with trial site).

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