A Study of ASKG712 in Patients With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05940428
• Other study ID #: ASKG712-CT-I-2
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 30, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2023
• Source: AskGene Pharma, Inc.
• Contact: Jing Chen, MD
• Phone: 086-15895835292
• Email: chenjing[@]ask-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
AskGene Pharma, Inc.	Suzhou Aosaikang Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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