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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Biological: ASKG712

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
14. Other protocol-specified inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASKG712; Multiple doses of ASKG712 by intravitreal injection	Biological: 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.; Other Names: AM712

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. 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	24 weeks
2. Incidence of non-ocular AEs	Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Area under the concentration time curve (AUC)	To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME	24 weeks
2. Maximum plasma concentration (Cmax)	To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME	24 weeks
3. Incidence of Anti-Drug Antibody (ADA)	To evaluate the immunogenicity of ASKG712 in patients with DME	24 weeks
4. Change From Baseline in BCVA in the Study Eye Over Time	To evaluate the efficacy of ASKG712 in patients with DME	24 weeks

Collaborators and Investigators

• Sponsor: AskGene Pharma, Inc.
• Collaborators: Suzhou Aosaikang Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Youxin Chen, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: ASKG712-CT-I-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD or supporting information available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No