An Open, Dose-escalation Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients in China
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a clinical study to evaluate the safety, tolerability and initial efficacy of SKG0106 intravitreal injection in diabetic macular edema (DME) patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Written informed consent must be obtained prior to all assessments.
• Age ≥18 years at screening.
• Type 1 or type 2 diabetes mellitus at screening.
• Study eye criteria:
‣ Decreased visual acuity attributable primarily to DME.
⁃ DME involves the macular center.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Eye & ENT Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Min Wang, Doctor
ykmarkwang@163.com
+86 13816630287
Time Frame
Start Date: 2024-05
Estimated Completion Date: 2026-01
Participants
Target number of participants: 18
Treatments
Experimental: Dose-escalation
SKG0106 one-time deliver
Related Therapeutic Areas
Sponsors
Collaborators: Lanyue Biotech (Hangzhou) Co., Ltd.
Leads: Wang Min