Neovascular Age-related Macular DegenerationPhase 1/2NCT05456828

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

A Phase 1/2 study testing ASKG712 in people with Neovascular Age-related Macular Degeneration, run by Visara, Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Neovascular Age-related Macular Degeneration
What is being tested?: ASKG712
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteChina
Study dates: 10 Feb 2023to 3 Nov 2025
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai General Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Multi-Center, Open-label, Single Ascending-Dose and Multiple Ascending-Dose Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Neovascular Age-related Macular Degeneration

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.

Conditions: Neovascular Age-related Macular Degeneration
Being tested: ASKG712

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASKG712Biological
Also called AM712, VIS-101
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.

Study groups in NCT05456828
Study group	Role	What they receive
ASKG712	Experimental	Single or multiple ascending dose of ASKG712 by intravitreal injection Receives: Biological: ASKG712

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
Anti-Drug Antibody
To evaluate the immunogenicity of ASKG712 in subjects with neovascular age-related macular degeneration (nAMD)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks
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)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
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)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
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)
Measured: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 20233 Nov 2025

First posted13 Jul 2022
Study start10 Feb 2023
Primary completion3 Nov 2025
Study completion3 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05456828
Sponsor's protocol ID: ASKG712-CT-I-1
Status last verified: Jun 2026
First submitted: 6 Jul 2022
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to make IPD or supporting information available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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