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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT04895293
Eligibility Criteria:
Inclusion Criteria:
• General Inclusion Criteria:
1. Male or female patients, 50 years of age or older at baseline
2. Patient has completed/signed an informed consent prior to any study-related procedures and is able to follow study instructions and likely to complete all required visits.
• Ocular Inclusion Criteria:
3. Best Corrected Visual Acuity (BCVA) 5 - 73 ETDRS letters (20/800-20/40 Snellen equivalent), inclusive, in study eye
4. Presence of choroidal neovascularization secondary to AMD
5. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging.
Exclusion Criteria:
• General Exclusion Criteria:
1. Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
2. History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator.
3. Participation in any investigational drug or device study within 30 days prior to baseline
4. History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• Ocular Exclusion Criteria:
5. Active ocular or periocular infections, malignancy
6. Aphakia
7. History of pars plana vitrectomy in the study eye
8. History of major ophthalmic surgery in the past 3 months in the study eye, or minor surgery in the past 30 days
9. History of significant ocular disease other than exudative AMD that may confound results
10. Uncontrolled glaucoma (defined as intraocular pressure \>21mm Hg despite treatment with ocular hypotensive medications at baseline).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
99 Years
Study:
NCT04895293
Study Brief:
Protocol Section:
NCT04895293