A Study of ASKG712 in Patients With Diabetic Macular Edema (NCT05940428) | Clinical Trial Compass
CompletedPhase 1
A Study of ASKG712 in Patients With Diabetic Macular Edema
China10 participantsStarted 2023-10-23
Plain-language summary
This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).
Who can participate
Age range
18 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
. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
. Hemoglobin A1c of less than or equal to 12%
. For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment
. Ability and willingness to undertake all scheduled visits and assessments
. Macular thickening secondary to DME involving the center of the fovea
. Decreased visual acuity attributable primarily to DME
Exclusion criteria
. History of allergy or current allergic response to ASKG712 or fluorescein
. Diseases that affect intravenous injection and venous blood sampling
. Uncontrolled blood pressure
. Systemic autoimmune diseases
. Previous anti-VEGF drug treatment
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
. Currently pregnant or breastfeeding, or intend to become pregnant during the study
. Any uncontrolled clinical disorders
. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye