A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration (NCT05456828) | Clinical Trial Compass
CompletedPhase 1/2
A Study of ASKG712 in Patients With Neovascular Age-Related Macular Degeneration
China56 participantsStarted 2023-02-10
Plain-language 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).
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this ASKG712 trial was a Phase 1/2 study focused mainly on tracking side effects rather than proving the treatment works, what does the safety data collected so far tell us about whether this drug looks promising or concerning for my situation?
2The trial has completed recruitment — does that mean results have been published or presented yet, and if so, what did they show about the types of ocular side effects patients experienced with ASKG712?
3Because this was an early-phase trial primarily measuring adverse events in the eye and the rest of the body, how does the level of evidence from this study compare to what we already know about established treatments like anti-VEGF injections for neovascular AMD?
4Given that this trial is now completed and I can no longer enroll, are there any follow-on or next-phase trials testing ASKG712 that might be worth looking into, or would you recommend focusing on a standard treatment path right now?
5How does ASKG712's mechanism of action differ from the anti-VEGF treatments I might already be a candidate for, and is there any reason based on my specific diagnosis to wait and see what comes from this trial's results before choosing a treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of ocular adverse events (AEs) of the study eyes
Timeframe: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks
2
Incidence of non-ocular adverse events (AEs)
Timeframe: Part 1: 6 weeks; Part 2: 20 weeks; Part 3: up to 36 weeks