NCT05456828CompletedPhase 1/2
A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 6 Jul 2022
- Start date
- 10 Feb 2023
- Primary completion date
- 3 Nov 2025
- Lead sponsor
- Visara, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT05456828
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 56
- From 10 Feb 2023 to the primary completion date, 3 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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；
Other illness
- 1\. History of uveitis in either eye；
- 2\. Current active inflammation or infection in the study eye;
- 4\. Subretinal hemorrhage area in the study eye ≥ 50% of total lesion size;
- 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;
Other
- 3\. Central foveal scar, fibrosis or atrophy of macular in the study eye;
- 5\. Scar or fibrosis area in study eyes ≥ 50% of total lesion size;
- 7\. Presence of retinal pigment epithelial tear;
- 15\. Pregnant or nursing women;
- 16\. Subjects should be excluded in the opinion of investigators.
Who the study is looking for
- 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.
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.