A Study of ASKG712 in Patients With Diabetic Macular Edema

AskGene Pharma

Status and phase: Active, not recruiting; Phase 1

Conditions: Diabetic Macular Edema

Treatments: Biological: ASKG712

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05940428

ASKG712-CT-I-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 1 patient group

ASKG712

Experimental group

Description:

Multiple doses of ASKG712 by intravitreal injection

Treatment:

Biological: ASKG712