A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
NCT ID: NCT06213038
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2023-05-05
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Level 1
SKG0106 One-Time Intraocular Injection Dose Level 1
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Dose Level 2
SKG0106 One-Time Intraocular Injection Dose Level 2
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Dose Level 3
SKG0106 One-Time Intraocular Injection Dose Level 3
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Interventions
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SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 50 years at screening;
Study Eye:
3. Diagnosis of nAMD as determined by the PI;
4. Active CNV lesions secondary to age-related macular degeneration (AMD);
5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment
Exclusion Criteria
2. Retinal pigment epithelial tear in the study eye at screening;
3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
5. History of retinal detachment or active retinal detachment in the study eye;
6. Any prior gene therapy.
50 Years
ALL
No
Sponsors
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Youxin Chen
OTHER
Responsible Party
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Youxin Chen
Professor
Principal Investigators
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Youchen Chen
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Eye & ENT Hospital of Fudan University
Shanghai, , China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Youxin Chen
Role: primary
Gezhi Xu
Role: primary
Other Identifiers
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SKG0106-001
Identifier Type: -
Identifier Source: org_study_id
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