A Study of ASKG712 in Patients With Diabetic Macular Edema

NCT05940428 | Active Not Recruiting Phase 1

• 1 other identifier: ASKG712-CT-I-2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 1. Area under the concentration time curve (AUC)

  24 weeks

• 2. Maximum plasma concentration (Cmax)

  24 weeks

• 3. Incidence of Anti-Drug Antibody (ADA)

  24 weeks

• 4. Change From Baseline in BCVA in the Study Eye Over Time

  24 weeks

Study Arms (1)

ASKG712

EXPERIMENTAL

Multiple doses of ASKG712 by intravitreal injection

Biological: ASKG712

Interventions

ASKG712 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.

Also known as: AM712

ASKG712

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AskGene Pharma, Inc.: lead
• Suzhou Aosaikang Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Study Officials

• Youxin Chen, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: July 11, 2023
• Study Start: October 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)