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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02355028
Eligibility Criteria:
Inclusion Criteria:
* Sign written informed consent form;
* Wet AMD;
* IVT anti-VEGF therapy for at least 6 months and a maximum of 7 years since the 3rd loading dose;
* BCVA 50 letters (approximate Snellen equivalent 20/100) or better in the study eye;
* Demonstrate ability to administer eye drops (subject or care-giver);
* CNV recently demonstrated high need for frequent anti-VEGF therapy and a sustained functional and clear anatomical response to the therapy in the study eye;
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Any active ocular or periocular infection or intraocular inflammation;
* Current or history of macular or retinal disease (if visually significant) other than wet AMD in the study eye;
* Current clinically significant vitreous hemorrhage or history of rhegmatogenous retinal detachment affecting the macula in the study eye;
* History of hypersensitivity to any of the study drugs or clinically relevant sensitivity to fluorescein dye or povidone iodine;
* Women of child-bearing potential;
* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of investigational product;
* Other protocol-specified exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT02355028
Study Brief:
Protocol Section:
NCT02355028