NCT05940428CompletedPhase 1
A Study of ASKG712 in Patients With Diabetic Macular Edema
A Multicenter, Non-Randomized, Open-Label, Multiple-Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASKG712 Following Intravitreal Administration in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 11 May 2023
- Start date
- 23 Oct 2023
- Primary completion date
- 21 Oct 2024
- Lead sponsor
- Visara, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT05940428
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 23 Oct 2023 to the primary completion date, 21 Oct 2024
- 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
- Previous anti-VEGF drug treatment
- Uncontrolled previous or current glaucoma in the study eye
- Previous intraocular operations in the study eye
Other illness
- History of allergy or current allergic response to ASKG712 or fluorescein
- Diseases that affect intravenous injection and venous blood sampling
- Systemic autoimmune diseases
- 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
- History of intraocular or periocular corticosteroid treatment in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- History of uveitis in either eye
Other
- Uncontrolled blood pressure
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Other protocol-specified inclusion/exclusion criteria may apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.