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NCT05940428

A Study of ASKG712 in Patients With Diabetic Macular Edema

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
AskGene Pharma, Inc.·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting
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Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
ASKG712
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
AskGene Pharma, Inc.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
Jul 30, 2023
End date
Jul 01, 2025
Enrollment
26 participants
Primary outcome

1. Incidence of ocular adverse events (AEs) of the study eyes,2. Incidence of non-ocular AEs

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).

ICD-10 classifications
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05940428
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05940428 through Pure Global AI's free database. This Phase 1 trial is sponsored by AskGene Pharma, Inc. and is currently Not yet recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 26 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.