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 who have Type 2 diabetes, are being treated with premixed insulin and metformin, and have been diagnosed with diabetic macular edema (a swelling in the central part of the retina) that affects the centre of their vision.
• People whose eye scan (a specific type of retinal imaging called OCT Heidelberg Spectralis) shows swelling in the central area of the retina in the eye being studied; if both eyes are affected, the eye with the greater swelling would be selected for the study.
• People whose reduced vision is mainly caused by the diabetic macular edema.
• People whose eyes are clear enough (no cloudiness) and whose pupils can be dilated enough to allow proper retinal imaging.
• People who are able to understand what the study involves and are willing to sign a written consent form.

Who may not be able to join:

• People under 18 years old or over 85 years old.
• People who have Type 1 diabetes (also known as insulin-dependent diabetes).
• Women who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months, who have diabetes.
• People who have had a heart attack within the 3 months before screening.
• People who have had a mini-stroke (TIA), or any type of stroke within the 3 months before screening.
• People whose diabetes is poorly controlled, defined as having an HbA1c blood sugar level of 12% or higher at screening, or who were hospitalised for a serious diabetes-related emergency (diabetic ketoacidosis or hyperosmolar coma) within the 4 months before screening.
• People whose kidneys are not filtering well enough, based on a specific blood test result below a certain threshold at screening (confirm with trial site).
• People with severe liver disease classified at a specific stage called Child-Turcotte-Pugh class C at screening.
• People who have previously been treated with a specific class of diabetes medications called thiazolidinediones (such as rosiglitazone or pioglitazone).
• People who have been taking a class of diabetes medications called SGLT2 inhibitors (such as dapagliflozin, canagliflozin, or empagliflozin) within the 3 months before screening.
• People with a known allergy or sensitivity to any of the study medications.
• People who have taken part in another clinical trial involving an experimental drug or device — either taken by mouth/injection or used in the eye — within the 6 months before screening.
• People whose macular swelling is caused by something other than diabetes, such as a blocked vein in the retina, abnormal blood vessel growth, or eye inflammation.
• People who have a history of swelling in the retina following eye surgery (known as Irvine-Gass syndrome).
• People who have had cataract surgery within the 3 months before screening.
• People who have previously had laser treatment directed at the central part of the retina (macular laser).
• People who have had a specific type of laser treatment for diabetic eye disease (panretinal photocoagulation, or PRP) within the 6 months before screening.
• People who have had injections into the eye (anti-VEGF or steroid injections) within the 6 months before screening.
• People who have used steroid or anti-inflammatory eye drops within the 1 month before screening.
• People currently using a specific type of eye drop used for glaucoma called prostaglandin analogs (such as latanoprost, travoprost, or similar).
• People who have previously had surgery inside the eye (vitrectomy) or a procedure to support a detached retina (scleral buckling).
• People whose eye scan shows significant pulling on the central retina from scar tissue or membranes on the retinal surface.
• People who have a pulling-type retinal detachment in the central retina that would require surgery.
• People whose eye scan shows other problems in the central retina, such as scars or holes.
• People who have abnormal new blood vessel growth on the iris (the coloured part of the eye).
• People who show signs of retinal damage caused by high blood pressure.
• People who have glaucoma.
• People who have no natural lens in their eye (aphakia).
• People who have had a specific type of laser procedure used after cataract surgery (YAG laser capsulotomy) within the 3 months before screening.
• People who have an active eye surface infection that has not yet been treated.
• People whose non-study eye is receiving injections at the same time as the study eye.

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