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CompletedNCT05456828Updated Jun 12, 2026

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

A Phase 1/2 interventional study of ASKG712 in Neovascular Age-related Macular Degeneration, sponsored by Visara, Inc.. Completed at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Visara, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
50 Years to 80 Years
Sex
All
01

Study summary

The purpose of the Phase 1/2a 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).

Read the detailed description

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

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

Part 3 of the study is a Phase 2a, multicenter, open-label, randomized, multiple ascending-dose (3 loading doses) expansion study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the 3.0 mg and 6.0 mg doses of ASKG712 in subjects with nAMD.

For Parts 1 and 2, 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. For Part 3 subjects will be randomized 2:1 to the 6.0mg and 3.0mg dose arms.

02

Conditions studied

  • Neovascular Age-related Macular Degeneration
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In context

Lead sponsor

Visara, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 the opinion of the 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    ASKG712

    Single or multiple ascending dose of ASKG712 by intravitreal injection

    Biological: ASKG712

Interventions

  • BiologicalASKG712

    ASKG712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.

    Also known as: AM712, VIS-101

06

What researchers measure

Primary outcomes

  1. Incidence of ocular adverse events (AEs) of the study eyes

    Any relevant ocular observations assessed by best corrected visual acuity (BCVA), slit lamp examination, ophthalmoscopy, intraocular pressure, fundus photography, optical coherence tomography (OCT) and angiography

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

  2. Incidence of non-ocular adverse events (AEs)

    Any changes of clinical safety observations assessed by vital signs, electrocardiograph (ECG), clinical laboratory tests and physical examination

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

Secondary outcomes

  1. Area under the concentration time curve (AUC)

    To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

  2. Maximum plasma concentration (Cmax)

    To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

  3. Anti-Drug Antibody

    To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

  4. Mean change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score

    To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

  5. Mean change from baseline in central subfield thickness (CST) of macula measured by optical coherence tomography (OCT)

    To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks

  6. Mean change from baseline in choroidal neovascularization area measured by fundus angiography

    To evaluate the efficacy of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)

    Time frame: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

07

Study locations

1 site
  • Shanghai General Hospital
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make IPD or supporting information available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05456828
Lead sponsor
Visara, Inc.
Collaborators
Suzhou Aosaikang Biopharmaceutical Co., Ltd., AskGene Pharma, Inc.
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Feb 10, 2023
Primary completion
Nov 3, 2025
Completion
Nov 3, 2025
Last update
Jun 12, 2026

Study contacts

Kun Liu, MD
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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