Phase 2 Retinal Vein Occlusion and Diabetic Macular Oedema Trial, Recruiting

Written by an AI model from 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 aged 18 years or older.
• People who have been diagnosed with type 1 or type 2 diabetes, shown by currently taking insulin, currently taking diabetes tablets, or having a diagnosis confirmed by a doctor.
• People who have a specific type of diabetes-related eye condition (diabetic macular edema, or DME), where fluid builds up in the central part of the retina, confirmed by eye imaging tests.
• People whose diabetes blood sugar control result (HbA1c) is 12% or below at the time of screening.
• People whose vision in the eye being studied falls within a specific range — not better than 20/50 and not worse than 20/320 on a standard eye chart; and whose other eye is no worse than 20/400.
• People whose retinal swelling measurement (central subfield thickness) is at least 325 µm on a specific eye scan (SD-OCT).
• People whose eye pressure is 21 mmHg or below, using no more than two pressure-lowering eye drops.
• People who are able to understand and agree to take part in the study (provide informed consent).
• People who are able and willing to follow the study schedule and requirements.
• Women who could become pregnant must agree to use reliable contraception, or abstain from sex, for the full duration of the study and for 28 days after the last dose of the study drug.
• Men must agree to use reliable contraception, or abstain from sex, for the full duration of the study and for 28 days after the last dose of the study drug.

Who may not be able to join:

• People who weigh less than 55 kg.
• People whose macular edema (swelling in the eye) appears to be caused by something other than diabetes.
• People who have a more advanced form of diabetic eye disease (proliferative diabetic retinopathy) or abnormal blood vessel growth in the front part of the eye, in the eye being studied.
• People whom the investigating doctor believes would be unable to follow the study requirements.
• People who are pregnant or currently breastfeeding.
• People who have had a specific type of laser eye treatment (panretinal or scatter laser photocoagulation) within the 12 months before screening.
• People who have used steroid or anti-inflammatory eye drops in the study eye, or anti-inflammatory tablets, within 30 days before screening.
• People who have active inflammation in the eye, or who have had any inflammation inside the eye within the past year.
• People who have previously received certain treatments for DME in or around the eye, including:
  • Anti-VEGF injections (such as bevacizumab, ranibizumab, aflibercept, faricimab, or brolucizumab) within 6 weeks of screening.
  • Steroid injections into or near the eye (such as triamcinolone or dexamethasone) within 12 months of screening, or a slow-release fluocinolone acetonide implant within 3 years of screening.
• People who have had laser treatment specifically for DME in the study eye within 6 months before screening.
• People who have no natural lens and no lens capsule remaining in the study eye.
• People who have had a specific laser procedure (YAG laser capsulotomy) in the study eye within 2 months before screening.
• People whose systemic (whole-body) steroid medication has changed within 3 months before screening.
• People who have had any eye surgery in the study eye within 12 weeks before screening.
• People who have severe loss of blood supply to the central area of the retina in the study eye, as measured by specific eye imaging tests (confirm with trial site).
• People who have abnormal blood vessel growth in the study eye caused by an eye condition other than diabetes (such as age-related macular degeneration or high short-sightedness).
• People who have, or have had, certain viral, bacterial, fungal, or other infections of the eye, including herpes-related eye infections, vaccinia, varicella, mycobacterial eye infections, fungal eye disease, or infectious retinitis in the study eye.
• People with any health condition or history that, in the investigating doctor's opinion, would make treatment or follow-up unsafe or unlikely to be beneficial.
• People with any other condition in the study eye (such as a macular hole, retinal vein blockage, or other retinal problems) that could affect how study results are interpreted, in the opinion of the investigating doctor.
• People with cloudiness of the lens or cornea in the study eye that prevents a clear view of the back of the eye, in the opinion of the investigating doctor.
• People who have a known allergy or sensitivity to any ingredient in the study drug.
• People who are currently taking certain antiviral medications called NRTIs, including (but not limited to) Abacavir, Emtricitabine, Lamivudine, or Zidovudine, or any medications sold under trade names including Atripla, Biktarvy, Truvada, or others in this drug class.
• People who have a history of taking medications known to cause damage to the retina, such as hydroxychloroquine, chloroquine, pentosan polysulfate sodium, or amiodarone.
• People with a significant unstable medical condition (other than diabetes) that could pose a health risk, or who have significant abnormal blood test results, as judged by the investigating doctor.
• People who have significantly abnormal liver or kidney function at screening — specifically, liver enzyme levels more than 3 times the normal upper limit, or a kidney filtration rate below 30 mL/min/1.73m².
• People with active cancer, or a history of cancer — with some exceptions for certain skin cancers, cervical or prostate pre-cancers, or cancers that were fully treated with no signs of return for at least 3 years (confirm specific exceptions with trial site).
• People who have taken another experimental drug within 6 weeks (or 5 half-lives of that drug, whichever is longer) before screening.
• People who have taken part in another clinical trial within 12 weeks before screening — though trials involving only observation, vitamins, supplements, or diet are generally not exclusionary (confirm with trial site).
• People who plan to move away from the study location within the next 2 months.

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