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 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT03359551
Eligibility Criteria:
Key Inclusion Criteria:
* Are willing and able to provide informed consent for participation in the study.
* Have a clinical phenotype and confirmed genetic diagnosis of CHM.
* Have active disease clinically visible within the macular region.
* Are willing and able to undergo ophthalmic examinations once every 4 months for up to 20 months.
* Have a BCVA better than or equal to 6/60 (20/200; decimal 0.1; LogMAR 1.0; 34-38 ETDRS letters) in at least one eye.
Key Exclusion Criteria:
* Have a history of amblyopia in the eligible eye.
* Have any other significant ocular or non-ocular disease/disorder in the eligible eye which, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or influence the subject's ability to participate in the study.
* Have participated in an interventional research study in the past 6 months.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03359551
Study Brief:
Protocol Section:
NCT03359551