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 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT05456828
Eligibility Criteria:
Inclusion Criteria:
* 1\. Signed the informed consent form;
* 2\. Male or female subjects with 50\~80 years of age;
* 3\. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesions secondary to neovascular age-related macular degeneration(nAMD);
* 4\. Total lesion area ≤ 12 disc area(DA);
* 5\. BCVA letter score measured at screening of 19\~78 letters.
Exclusion Criteria:
* 1\. History of uveitis in either eye；
* 2\. Current active inflammation or infection in the study eye;
* 3\. Central foveal scar, fibrosis or atrophy of macular in the study eye;
* 4\. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
* 5\. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
* 6\. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of ASKG712 or require medical or surgical intervention.
* 7\. Presence of retinal pigment epithelial tear;
* 8\. Previous intraocular operations in the study eye;
* 9\. Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* 10\. Previous anti-VEGF drug treatment within 60 days prior to screening；
* 11\. Diseases that affect intravenous injection and venous blood sampling;
* 12\. Systemic autoimmune diseases;
* 13\. Any uncontrolled clinical disorders;
* 14\. History of allergy or current allergic response to ASKG712 or fluorescein;
* 15\. Pregnant or nursing women;
* 16\. Subjects should be excluded in the opinion of investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT05456828
Study Brief:
Protocol Section:
NCT05456828