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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01802866
Eligibility Criteria:
Inclusion Criteria:
1. Males or females, age ≥55 years.
2. Clinical diagnosis of GA associated with AMD
3. Able and willing to provide written informed consent.
4. Able to reliably administer oral medication by self or with available assistance.
Exclusion Criteria:
1. Active CNV or presence of an active ocular disease.
2. Known serious allergy to the fluorescein sodium for injection in angiography.
3. Pre-specified laboratory abnormalities at screening.
4. Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)
5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding
6. Female subjects who are pregnant or lactating.
7. Female subjects of childbearing potential and male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control from screening through 30 days after completion of the study.
8. Unstable or poorly controlled medical or ophthalmic conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01802866
Study Brief:
Protocol Section:
NCT01802866