Diabetic Macular EdemaPhase 1NCT05940428
A Study of ASKG712 in Patients With Diabetic Macular Edema
A Phase 1 study testing ASKG712 in people with Diabetic Macular Edema, run by Visara, Inc. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 21 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
Show all 14Show fewer
- 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
- Uncontrolled previous or current glaucoma in the study eye
- Previous intraocular operations in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- History of uveitis in either eye
- Other protocol-specified inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: 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
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).
Read the detailed description
Part 1 of this study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.
Part 2 of this study was planned to be a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Part 2 was not initiated due to a strategic decision by the sponsor not related to safety or efficacy.
- Conditions
- Diabetic Macular Edema
- 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 group | Role | What they receive |
|---|---|---|
| ASKG712 | Experimental | Multiple doses 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 derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography
Measured: 24 weeks
Incidence of non-ocular AEs
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
Measured: 24 weeks
Secondary outcomes (4)
Area under the concentration time curve (AUC)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Measured: 24 weeks
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
Measured: 24 weeks
Incidence of Anti-Drug Antibody (ADA)
To evaluate the immunogenicity of ASKG712 in patients with DME
Measured: 24 weeks
Change From Baseline in BCVA in the Study Eye Over Time
To evaluate the efficacy of ASKG712 in patients with DME
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start23 Oct 2023
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visara, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Aosaikang Biopharmaceutical Co., Ltd., AskGene Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Youxin Chen, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940428
- Sponsor's protocol ID
- ASKG712-CT-I-2
- Status last verified
- Jun 2026
- First submitted
- 11 May 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05940428
- Acronym / sponsor ID
- ASKG712-CT-I-2
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Visara, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Aosaikang Biopharmaceutical Co., Ltd., AskGene Pharma, Inc.
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Part 1 of this study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.
Part 2 of this study was planned to be a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Part 2 was not initiated due to a strategic decision by the sponsor not related to safety or efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASKG712 | Experimental | Biological: ASKG712Multiple doses of ASKG712 by intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASKG712Also: AM712, VIS-101ASKG712 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. | Biological | ASKG712 |
Primary outcome
Incidence of ocular adverse events (AEs) of the study eyes
Time frame: 24 weeks
Any relevant ocular observations derived from best corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, ophthalmoscopy, optical coherence tomography (OCT), fundus photography, and angiography
Incidence of non-ocular AEs
Time frame: 24 weeks
Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
4 secondary outcomes
Area under the concentration time curve (AUC)
Time frame: 24 weeks
Maximum plasma concentration (Cmax)
Time frame: 24 weeks
Incidence of Anti-Drug Antibody (ADA)
Time frame: 24 weeks
Change From Baseline in BCVA in the Study Eye Over Time
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD or supporting information available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youxin Chen, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASKG712 in people with Diabetic Macular Edema, run by Visara, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular adverse events (AEs) of the study eyes (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.