A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients
NCT06237777 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-04-30
Summary
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
Conditions
Interventions
- GENETIC
-
SKG0106 intravitreal injection dose level 1, 2 or 3
SKG0106 is a recombinant adeno-associated virus (rAAV) vector-based in vivo gene therapeutic product.
Sponsors & Collaborators
-
Lanyue Biotech (Hangzhou) Co., Ltd.
collaborator INDUSTRY -
Wang Min
lead OTHER
Principal Investigators
-
Min Wang, Doctor · Eye & ENT Hospital of Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-31
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
Countries
- China
Study Locations
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