A Study of ASKG712 in Patients With Diabetic Macular Edema
- Conditions
- Diabetic Macular Edema
- Interventions
- Biological: ASKG712
- Registration Number
- NCT05940428
- Lead Sponsor
- AskGene Pharma, Inc.
- Brief 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).
- Detailed 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 & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASKG712 ASKG712 Multiple doses of ASKG712 by intravitreal injection
- Primary Outcome Measures
Name Time Method 2. Incidence of non-ocular AEs 24 weeks Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests
1. Incidence of ocular adverse events (AEs) of the study eyes 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
- Secondary Outcome Measures
Name Time Method 1. Area under the concentration time curve (AUC) 24 weeks To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
3. Incidence of Anti-Drug Antibody (ADA) 24 weeks To evaluate the immunogenicity of ASKG712 in patients with DME
2. Maximum plasma concentration (Cmax) 24 weeks To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME
4. Change From Baseline in BCVA in the Study Eye Over Time 24 weeks To evaluate the efficacy of ASKG712 in patients with DME
Trial Locations
- Locations (1)
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China