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SKG0106

Phase 1

Neovascular Age-related Macular Degeneration | Gene therapy | Ophthalmology |cbdMD, Inc.|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

SKG0106 · 1 trial · 1 indication

Phase 1 1
NCT05986864Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)Neovascular Age-related Macular Degeneration
RECRUITING68 Analytics
PHASE1RECRUITING
Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
NCT0598686468
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Study Endpoints

Primary Endpoints

Characteristics of dose limiting toxicities (DLTs)
4 Weeks
Type, severity, and incidence of ocular and systemic adverse events (AEs)
52 Weeks

Secondary Endpoints

Mean change from baseline in best corrected visual acuity (BCVA) at each visit
52 Weeks
Mean change from baseline in central subfield thickness (CST) at each visit
52 Weeks
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit
52 Weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase I: Low doseEXPERIMENTALSKG0106 One-Time Intraocular Injection Dose Level 1
Phase I: Medium doseEXPERIMENTALSKG0106 One-Time Intraocular Injection Dose Level 2
Phase I: High doseEXPERIMENTALSKG0106 One-Time Intraocular Injection Dose Level 3

Interventions

NameTypeDescription
SKG0106GENETICSKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: 1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol; 2. Aged ≥ 50 years at screening; Study Eye: 3. Diagnosis of nAMD as determined by the PI; 4. Active CNV lesions secondary to age-relate...

Countries:United StatesChina
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