Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
NCT ID: NCT05986864
Last Updated: 2025-01-09
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/PHASE2
68 participants
INTERVENTIONAL
2024-02-23
2026-01-30
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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Phase I: Low dose
SKG0106 One-Time Intraocular Injection Dose Level 1
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Phase I: Medium dose
SKG0106 One-Time Intraocular Injection Dose Level 2
SKG0106
SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
Phase I: High dose
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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Skyline Therapeutics (US) Inc.
INDUSTRY
Responsible Party
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Locations
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Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Texas
Katy, Texas, United States
Wagner Kapoor Research Institute
Norfolk, Virginia, United States
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Eye Hospital, WMU (Zhejiang Eye Hospital)
Wenzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Marie Chin
Role: primary
Chris Riebling
Role: primary
Other Identifiers
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SKG0106-101
Identifier Type: -
Identifier Source: org_study_id
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