Macular Degeneration Trial, Not Yet 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:

All participants must meet these general criteria:

• Adults between 55 and 80 years old (inclusive)
• Considered medically stable and able to understand and follow the study procedures, as determined by the trial investigator
• Having sufficient hearing, vision, and language ability to give consent and take part in eye imaging, memory testing, and other procedures (hearing aids are permitted)
• Able to reliably communicate with study staff about any side effects or medications being taken
• Able to provide signed written consent; people with mild Alzheimer's disease must be able to give agreement themselves and be accompanied by a relative or caregiver who can provide written consent on their behalf
• Taking only medications that have been stable for at least one month before the screening visit (including antidepressants with no significant anticholinergic effects, if the person is not currently depressed and has had no major depression in the past year)

Healthy older adults (without eye or memory conditions) must also meet these criteria:

• A score above 27 on a standard memory and thinking test (MMSE)
• A score of 0 on a standard cognitive assessment scale (CDR)
• No current or past history of close biological relatives diagnosed with, or suspected to have, Alzheimer's disease, and no ongoing personal concerns about memory
• If test results are available, no presence of the APOE e4 gene variant and no abnormal amyloid protein build-up found through blood, brain scan, or spinal fluid testing
• No diagnosed eye or retinal diseases other than short-sightedness or long-sightedness
• No diagnosed neurological or neurodegenerative conditions

People with a specific type of age-related macular degeneration (dry AMD with geographic atrophy) must also meet these criteria:

• A score above 27 on the MMSE memory test
• A score of 0 on the CDR cognitive scale
• A confirmed advanced stage of dry (non-neovascular) AMD, as diagnosed by a qualified specialist
• No current or past evidence of abnormal blood vessel growth under the retina (choroidal neovascularisation) in the eye being studied
• Vision in the study eye that meets or exceeds a standard threshold (best corrected visual acuity of 20/80 or better)
• A notable difference between standard vision and low-light vision (more than 5 letters difference on an eye chart)
• A geographic atrophy lesion size within a specific range (approximately 0.5 to 4.0 disc areas, confirm with trial site for exact measurements)
• Not currently being treated with a complement system inhibitor (a type of injection used for dry AMD)

People with mild cognitive impairment (MCI) due to Alzheimer's disease, or mild Alzheimer's disease, must also meet these criteria:

• A score above 21 on the MMSE memory test
• A CDR score between 0.5 and 1.0
• A score on another memory test (MoCA) between 18 and 26 at screening
• Prior test results (from blood, brain scan, or spinal fluid) showing biological signs consistent with Alzheimer's disease, confirmed through medical records
• A formal clinical diagnosis of MCI due to Alzheimer's disease or mild Alzheimer's disease, from a qualified specialist or memory clinic
• A study partner (such as a family member, close friend, or caregiver) available to attend appointments alongside them
• Concurrent participation in other clinical trials for MCI or Alzheimer's disease is permitted, including trials using investigational drugs, because this study involves no treatment

Who may not be able to join:

Medical history:

• People with a history of severe allergic (anaphylactic) reactions to any medication
• People with a history of allergic reaction to a dye called ICG (indocyanine green)
• People with a history of sensitivity or allergic reaction to iodine
• People with a history of significant liver disease
• People with a score above 2 on a scale used to assess blood vessel-related memory decline (Modified Hachinski Ischemia Scale)
• People with a known sensitivity to eye drops used to dilate pupils (tropicamide) or similar medications

Eye and neurological conditions:

• People with other eye or neurological conditions that could affect the results, such as diabetic retinopathy or glaucoma

Mental health screening:

• People who score above 6 on a short depression screening tool (Geriatric Depression Scale, 15-item version)

Other health conditions:

• People diagnosed with an autoimmune condition, including but not limited to psoriasis, lupus, rheumatoid arthritis, Crohn's disease, multiple sclerosis, or alopecia areata
• People with unstable heart, lung, or digestive system conditions (including uncontrolled high blood pressure)
• People with a history of alcohol or substance misuse or dependence within the past two years
• People with a history of schizophrenia, psychotic episodes, agitation, or significant behavioural problems in the past three months
• People who, in the investigator's judgment, are unlikely to follow study procedures
• People with significant unstable health conditions, including: a heart attack within the past six months; severe or unstable heart disease; uncontrolled high blood pressure (systolic above 170 or diastolic above 100); diabetes that is poorly controlled or requires insulin; a history of narrow-angle glaucoma symptoms (such as eye pain or vision changes); or a history of elevated eye pressure above 20 mmHg

Medications:

• People who have a weakened immune system or are taking medications that suppress the immune system (such as corticosteroids, excluding anti-inflammatory drugs like NSAIDs)
• People currently taking, or who have taken in the past three months, a biologic immunosuppressive therapy (a long list of specific medications is specified — confirm with the trial site)
• People using narcotic or antipsychotic medications daily (low doses for off-label use may be considered at the investigator's discretion if stable for four weeks before screening)
• People who have started or recently changed anti-Parkinson's medications within two months before screening (low doses for off-label use may be considered if stable for two months — confirm with trial site)
• People who have started or recently changed anti-seizure medications within two months before screening (same conditions as above apply — confirm with trial site)
• People who have newly started certain blood pressure or nerve-acting medications within four weeks before screening (including centrally active beta-blockers, methyldopa, and clonidine)
• People who have newly started antipsychotic or narcotic pain medications within four weeks before screening
• People who have newly started or are regularly using long-acting sleeping or anxiety medications (benzodiazepines or barbiturates) within four weeks before screening
• People who have started or changed the dose of an antidepressant within four weeks before screening
• People who have previously or are currently being treated for dry AMD with a complement system inhibitor

Blood and laboratory test results at screening:

• People with uncontrolled high blood pressure, abnormal blood pressure readings, or abnormal heart rate at screening
• People with significantly abnormal liver enzyme results (ALT or AST more than twice the normal upper limit, or total bilirubin more than twice the normal upper limit)
• People with abnormal pancreas-related enzyme levels (amylase or lipase more than twice the normal upper limit)
• People with insulin-dependent diabetes or a blood sugar control reading (HbA1C) of 6.5% or higher
• People with abnormal liver function results identified at screening
• People with significantly reduced kidney function (GFR of 45 ml/min/1.73m² or less, confirm measurement method with trial site)
• People with certain blood count abnormalities, including low haemoglobin (below 10g/dL), low white blood cell count, or low platelet count
• People with a known infection with HIV, hepatitis B, or hepatitis C
• People with a positive drug screen result that cannot be explained by their current medications

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