Phase 1 Macular Degeneration 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 are willing to take the medication tacrolimus and willing to stop any medications that are known to interact strongly with it.
• People who are able and willing to attend all scheduled appointments up to the 52-week visit.
• People currently taking an antidepressant who are on a stable, effective dose and are willing to continue taking it reliably for as long as needed.
• People who are medically suitable and willing to undergo monitored sedation during eye surgery (vitrectomy and injection under the retina).
• People who agree to follow local and institutional policies relating to active COVID-19 infections.
• People who agree not to participate in another interventional study until after the 52-week visit.
• Women who are not pregnant, and who are either not of childbearing potential, or who agree to use contraception from the time of consent through at least 52 weeks after receiving the study treatment.
• Women who agree not to breastfeed from screening through 52 weeks after receiving the study treatment.
• Women who agree not to donate eggs from the first dose of study treatment through 52 weeks after receiving it.
• Men with a female partner of childbearing potential (including a breastfeeding partner) who agree to use contraception throughout the treatment period and for 52 weeks after receiving the study treatment.
• Men who agree not to donate sperm during the treatment period and for 52 weeks after receiving the study treatment.
• Men with a pregnant partner who agree to remain abstinent or use a condom for the duration of the pregnancy and for 52 weeks after receiving the study treatment.
• People who have age-related macular degeneration (AMD) in both eyes, with a specific type of damage called geographic atrophy (GA) — areas where the layer of cells beneath the retina has been lost — present in the study eye (GA in one eye only may also be acceptable as long as both eyes show AMD).
• People who have no known history of the "wet" form of AMD (where abnormal blood vessels grow under the retina) in either eye, confirmed by specialised eye imaging.
• People who show no signs of fluid leakage in the eye, as confirmed by specific eye imaging tests.
• People whose eyes are clear enough and whose pupils can dilate sufficiently to allow good quality imaging of the back of the eye.
• People who have had the natural lens of the eye replaced with an artificial lens (pseudophakic).
• Group 1 only: People whose vision in the study eye falls within a specific range of low vision on a standardised eye chart test, and whose area of GA is no larger than 30.5 mm².
• Group 2 only: People whose vision in the study eye falls within a different, slightly better range on the standardised eye chart test, whose GA area falls within a specific size range, and whose results on a light sensitivity test are consistent between two measurements.

Who may not be able to join:

• People with a history of recurring chickenpox/shingles virus (varicella zoster) infections, or a recent infection within 4 weeks of the baseline visit, or a blood test showing a current active infection with this virus.
• People with a history of recurring cytomegalovirus (CMV) infections, or a recent CMV infection within 4 weeks of the baseline visit, or a blood test showing a current active CMV infection.
• People who test positive for tuberculosis (TB) on a specific blood test within 6 months before screening.
• People with a history or suspected active infection of toxoplasmosis, or a blood test showing a current active toxoplasmosis infection within 4 weeks of the baseline visit.
• People with an active infection (in the eye or elsewhere in the body) requiring long-term or ongoing use of antibiotics or anti-infective medications.
• People with a current cancer diagnosis or a history of cancer within the past 5 years, except for certain skin cancers or cervical changes that have been successfully treated.
• People who have had a solid organ transplant (such as a kidney or liver) or a bone marrow transplant.
• People who have any condition that would make it unsafe to take tacrolimus as an immune-suppressing medication.
• People who are currently using, or have recently used within approximately 6 weeks, medications that suppress the immune system (other than low-dose steroids within a certain limit).
• People who have had a heart attack in the past 12 months and whose heart condition is currently unstable or causing symptoms such as chest pain or breathlessness.
• People whose heart electrical activity reading (ECG) shows results that could affect their safety or ability to participate in the study (confirm with trial site).
• People whose diastolic blood pressure (the lower number) is above 95 mmHg at screening or the baseline visit, after repeated measurements.
• People whose kidneys are functioning at a significantly reduced level, based on a specific calculation using blood test results (eGFR of 30 mL/min or below).
• People whose liver enzyme or liver function blood test results are more than twice the upper limit of the normal range.
• People with severely low red blood cell levels (anaemia), very low white blood cell counts, very low platelet counts, or abnormally high red blood cell concentration.
• People with a blood sugar control reading (HbA1c) above 8.5%, indicating poorly controlled diabetes.
• People with significant problems with blood clotting, based on specific blood test results.
• People who test positive for syphilis, Lyme disease, HIV, hepatitis A, B, or C, or an active chickenpox/shingles virus (VZV) infection.
• People with a history of familial adenomatous polyposis or inflammatory bowel diseases such as Crohn's disease or ulcerative colitis.
• People with a known allergy to eye drops used to dilate pupils or to fluorescein dye used in eye imaging.
• People who have previously received gene therapy or cell transplant therapy, including in a prior clinical study.
• People who have participated in a study of an experimental drug or procedure within 12 weeks before screening (with some exceptions noted in the trial protocol).
• People whose study eye has received an FDA-approved complement inhibitor injection within 24 weeks before screening (a washout period may make later eligibility possible — confirm with trial site).
• People who are unwilling to stop or avoid certain medications that can interfere with how tacrolimus works in the body, including some antibiotics, antifungals, anti-seizure medications, herbal supplements (such as St John's Wort), and certain blood thinners.
• People who test positive for recreational drugs on a urine screen, unless the drug is being taken for a documented medical condition under a doctor's supervision.
• People whose macular degeneration is caused by something other than AMD (such as inherited eye conditions or medication-related damage).
• People who have developed the "wet" (exudative) form of AMD in either eye.
• People whose fovea (the central part of the retina responsible for sharp vision) still has potentially viable cells within a certain distance of its centre, as assessed by the reading centre.
• People who have had vitrectomy, surgery under the macula, or any surgical treatment specifically for AMD in the study eye.
• People who have had certain previous eye treatments including photodynamic therapy, radiation to the eye, or a laser heating procedure for the retina.
• People who have had laser treatment for abnormal blood vessel growth, diabetic eye disease, retinal vein blockage, or diabetic retinopathy.
• People with certain structural abnormalities at the back of the eye (such as a membrane pulling on the retina) that could interfere with measurements or cause damage.
• People with a history of fluid-filled swelling in the macula, blockage of retinal blood vessels, a specific type of fluid buildup under the retina, a macular hole, or a splitting of retinal layers in the study eye.
• People with retinal tears or other retinal lesions at the edges of the retina that carry a risk of causing retinal detachment.
• People with active or past inflammation inside the eye, such as uveitis or inflammation of the optic nerve (other than glaucoma).
• People with a toxoplasmosis scar in the eye.
• People with certain pigmented lesions in or around the eye that carry characteristics associated with a higher risk of malignancy (confirm with trial site).
• People with severe short-sightedness beyond a certain level, or related damage to the back of the eye.
• People with glaucoma where eye pressure is not well controlled despite treatment, who need more than two medications to manage eye pressure, or who have had glaucoma filtration surgery.
• People who have had a corneal transplant.
• People who have no useful vision at all in their other (non-study) eye, or who have no other eye.
• People for whom pupil dilation is not possible or safe.
• People with any other eye condition that could interfere with imaging assessments used in the study.

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