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:

• Adults aged 18 years or older
• People who have been diagnosed with type 1 or type 2 diabetes
• People who are currently using insulin or oral diabetes medications on a regular basis to manage their diabetes
• People who live within a 2-hour drive of the hospital or clinic where the trial is being conducted
• People who have at least one eye that meets the specific eye-related criteria for the trial (see eye criteria below)
• People who are able and willing to use a home vision-testing device and a home eye-scanning device on their own or with family help, after receiving training
• People who are able and willing to give their informed consent to take part

Eye-specific criteria — the eye being studied must also meet these requirements:

• The eye has a specific type of swelling in the centre of the retina caused by diabetes (called diabetic macular oedema, or DME), confirmed by a retinal scan showing swelling above a certain thickness threshold
• The eye has a best-corrected vision level that falls within a specific range — not better than 20/32 and not worse than 20/320 — measured within seven days of joining the trial
• The eye has either never been treated for DME before, or has had a limited number of anti-VEGF injections (a type of eye injection) within specific time limits (confirm with trial site for the exact injection history requirements)
• The eye is clear enough, and the person is cooperative enough, to allow for good-quality retinal photographs and scans to be taken

Who may not be able to join:

• People whose general health is considered unstable by the investigators, including those with poorly controlled blood pressure, heart disease, kidney disease, or blood sugar levels
• People who have received a type of medication called anti-VEGF or pro-VEGF treatment (given into the body, not the eye) in the 4 months before joining, or who would need to use these medications during the trial
• People who have taken part in another clinical trial involving an unapproved drug within 30 days of joining
• People with a blood pressure reading above 180/110 — however, if blood pressure is brought below this level with medication, the person may still be considered (confirm with trial site)
• People who have had a heart attack, stroke, mini-stroke (TIA), a serious heart event requiring hospitalisation, or treatment for severe heart failure in the 4 months before joining
• Women who are pregnant, breastfeeding, or planning to become pregnant within the next 2 years
• People who are currently taking part in another clinical trial
• People who expect to move to a location more than a 2-hour drive from the trial site within the first 12 months of the study

Eye-specific exclusions — the eye being studied cannot have:

• Retinal swelling caused by something other than diabetes
• Any laser treatment, surgery, or steroid injections for DME in the eye in the past 12 months
• Anti-VEGF eye injections given for a condition other than DME (such as certain other eye diseases) in the past 6 months, or an anticipated need for such injections in the next 6 months
• Other eye conditions that could affect vision during the trial, such as blocked blood vessels in the eye, eye inflammation, or a certain type of glaucoma
• A cataract that, in the investigator's opinion, is significantly reducing vision (by 3 lines or more on an eye chart)
• Major eye surgery (including cataract removal, vitrectomy, or other procedures inside the eye) in the past 4 months, or surgery expected within 6 months of joining
• Uncontrolled glaucoma
• A significant active eye infection or inflammation, such as severe conjunctivitis or eyelid inflammation

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