A Study of ASKG712 in Patients With Diabetic Macular Edema

NCT ID: NCT05940428

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2025-12-31

Brief 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).

Detailed Description

The Part 1 of 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.

The Part 2 of study is a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASKG712

Multiple doses of ASKG712 by intravitreal injection

Group Type: EXPERIMENTAL

ASKG712

Intervention Type: BIOLOGICAL

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.

Interventions

ASKG712

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

AM712

Eligibility Criteria

Inclusion Criteria

1. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)

2. Hemoglobin A1c of less than or equal to 12%

3. 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

4. Ability and willingness to undertake all scheduled visits and assessments

5. Macular thickening secondary to DME involving the center of the fovea

6. Decreased visual acuity attributable primarily to DME

Exclusion Criteria

1. History of allergy or current allergic response to ASKG712 or fluorescein

2. Diseases that affect intravenous injection and venous blood sampling

3. Uncontrolled blood pressure

4. Systemic autoimmune diseases

5. Previous anti-VEGF drug treatment

6. Currently pregnant or breastfeeding, or intend to become pregnant during the study

7. Any uncontrolled clinical disorders

8. 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

9. History of intraocular or periocular corticosteroid treatment in the study eye

10. Uncontrolled previous or current glaucoma in the study eye

11. Previous intraocular operations in the study eye

12. Active intraocular or periocular infection or active intraocular inflammation in the study eye

13. History of uveitis in either eye

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Aosaikang Biopharmaceutical Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

AskGene Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youxin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

ASKG712-CT-I-2

Identifier Type: -

Identifier Source: org_study_id