Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT04269304
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥ 55 years with either intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes, i.e. large drusen \> 125 um and/or any definite hyper- or hypopigmentary abnormalities associated with medium or large drusen; or intermediate AMD as defined above in one eye (study eye) and advanced AMD (geographic atrophy or choroidal neovascularization secondary to AMD) in the other eye.
* Subjects should have media clarity and pupillary dilation for adequate imaging and functional tests.
Exclusion Criteria:
* Co-existent ocular disease, which might affect visual function or retinal morphology
* Established glaucoma in either study eye or fellow eye with evidence of visual field loss or retinal nerve fibre loss (ocular hypertension is not an exclusion criterion unless associated with visual field loss or retinal nerve fibre loss in either eye).
* Cataract sufficient to affect retinal imaging
* Myopia \> minus 6 diopters or a history of myopia \> minus 6 diopters if patient has had cataract / refractive surgery.
* Major ocular surgery 3 months prior or anticipated within the next 6 months following enrolment.
* Taking drugs known to cause retinal toxicity such as hydroxychloroquine or tamoxifen
* OCT evidence of geographic atrophy (or complete Retinal Pigment Epithelium (RPE) and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
* OCT evidence of choroidal neovascularization e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT04269304
Study Brief:
Protocol Section:
NCT04269304