Last updated: September 2, 2025
Sponsor: AskGene Pharma, Inc.
Overall Status: Active - Not Recruiting
Phase
1
Condition
Macular Degeneration
Geographic Atrophy
Treatment
ASKG712
Clinical Study ID
NCT05456828
ASKG712-CT-I-1
Ages 50-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Signed the informed consent form;
- Male or female subjects with 50~80 years of age;
- Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesionssecondary to neovascular age-related macular degeneration(nAMD);
- Total lesion area ≤ 12 disc area(DA);
- BCVA letter score measured at screening of 19~78 letters.
Exclusion
Exclusion Criteria:
- History of uveitis in either eye;
- Current active inflammation or infection in the study eye;
- Central foveal scar, fibrosis or atrophy of macular in the study eye;
- Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
- Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
- History or any concurrent ocular condition which, in opinion of investigator,could either confound interpretation of efficacy and safety of ASKG712 or requiremedical or surgical intervention.
- Presence of retinal pigment epithelial tear;
- Previous intraocular operations in the study eye;
- Uncontrolled previous or current glaucoma in either eye, or previous glaucomafiltering operation in the study eye;
- Previous anti-VEGF drug treatment within 60 days prior to screening;
- Diseases that affect intravenous injection and venous blood sampling;
- Systemic autoimmune diseases;
- Any uncontrolled clinical disorders;
- History of allergy or current allergic response to ASKG712 or fluorescein;
- Pregnant or nursing women;
- Subjects should be excluded in the opinion of investigators.
Study Design
Total Participants: 56
Treatment Group(s): 1
Primary Treatment: ASKG712
Phase: 1
Study Start date:
February 10, 2023
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Shanghai General Hospital
Shanghai, Shanghai
ChinaSite Not Available
Shanghai General Hospital
Shanghai 1796236, Shanghai Municipality 1796231
ChinaSite Not Available

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