A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration

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

The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) , multiple ascending-dose component (Part 2) and multiple-dose extension component (Part 3) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Signed the informed consent form;
    1. Male or female subjects with 50~80 years of age;
    1. Active sub-foveal or juxta-foveal choroidal neovascularization(CNV) lesionssecondary to neovascular age-related macular degeneration(nAMD);
    1. Total lesion area ≤ 12 disc area(DA);
    1. BCVA letter score measured at screening of 19~78 letters.

Exclusion

Exclusion Criteria:

    1. History of uveitis in either eye;
    1. Current active inflammation or infection in the study eye;
    1. Central foveal scar, fibrosis or atrophy of macular in the study eye;
    1. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
    1. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
    1. 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.
    1. Presence of retinal pigment epithelial tear;
    1. Previous intraocular operations in the study eye;
    1. Uncontrolled previous or current glaucoma in either eye, or previous glaucomafiltering operation in the study eye;
    1. Previous anti-VEGF drug treatment within 60 days prior to screening;
    1. Diseases that affect intravenous injection and venous blood sampling;
    1. Systemic autoimmune diseases;
    1. Any uncontrolled clinical disorders;
    1. History of allergy or current allergic response to ASKG712 or fluorescein;
    1. Pregnant or nursing women;
    1. 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

The Part 1 of study is a multicenter, open-label, sequentially, single ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

The Part 2 of study is a multicenter, open-label, sequentially, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD.

The Part 3 of study is a multicenter, open-label, randomized, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in subjects with nAMD at 2 recommanded dose levels.

Subjects will be sequentially enrolled into different dose-level cohorts following the "3+3" design to determine the maximum tolerated dose (MTD) or the maximum administered dose has been reached.

Connect with a study center

  • Shanghai General Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.