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NCT Number: NCT05940428

A Study of ASKG712 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).

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Other protocol-specified inclusion/exclusion criteria may apply

Treatment and study plan

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.

Other names: AM712, VIS-101

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Area under the concentration time curve (AUC)

    Time frame: 24 weeks

    To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME

  2. Maximum plasma concentration (Cmax)

    Time frame: 24 weeks

    To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME

  3. Incidence of Anti-Drug Antibody (ADA)

    Time frame: 24 weeks

    To evaluate the immunogenicity of ASKG712 in patients with DME

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

    Time frame: 24 weeks

    To evaluate the efficacy of ASKG712 in patients with DME

Sponsors and collaborators

Lead sponsor

Visara, Inc.

Industry

Collaborators

  • AskGene Pharma, Inc.
  • Suzhou Aosaikang Biopharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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