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

ASKG712-CT-I-2

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).

2023-07-30

2024-12-31

2025-07-01

Not yet recruiting

Early phase I

26

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2023-07-14