Diabetic Macular Edema
Conditions
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
Part 1 of this 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. Part 2 of this study was planned to be a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Part 2 was not initiated due to a strategic decision by the sponsor not related to safety or efficacy.
Interventions
BIOLOGICALASKG712
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.
Sponsors
Visara, Inc.
Suzhou Aosaikang Biopharmaceutical Co., Ltd.
AskGene Pharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of non-ocular AEs | 24 weeks | Any clinical safety observations assessed by physical examination, vital signs, electrocardiograph (ECG) and clinical laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration time curve (AUC) | 24 weeks | To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME |
| Maximum plasma concentration (Cmax) | 24 weeks | To evaluate the systemic pharmacokinetics of ASKG712 in patients with DME |
| Incidence of Anti-Drug Antibody (ADA) | 24 weeks | To evaluate the immunogenicity of ASKG712 in patients with DME |
| Change From Baseline in BCVA in the Study Eye Over Time | 24 weeks | To evaluate the efficacy of ASKG712 in patients with DME |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYouxin Chen, MD
Peking Union Medical College Hospital
Outcome results
None listed