Phase I/II Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Skyline Therapeutics (US) Inc.
Study ID
NCT05986864
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SKG0106 — GENETIC
    SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product

Study Details

This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.

Key Dates

Start date
Feb 23, 2024
Status verified
Jan 2025
Primary completion
Jan 31, 2026
Completion
Jan 30, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Low dose
    SKG0106 One-Time Intraocular Injection Dose Level 1
  • Experimental: Phase I: Medium dose
    SKG0106 One-Time Intraocular Injection Dose Level 2
  • Experimental: Phase I: High dose
    SKG0106 One-Time Intraocular Injection Dose Level 3

Primary Outcome Measure

Characteristics of dose limiting toxicities (DLTs) [ Time Frame: 4 Weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates of Florida - Saint PetersburgSt. PetersburgFlorida33711-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of TexasKatyTexas77494
Marie Chin
Charles C Wykoff, MD (PRINCIPAL_INVESTIGATOR)
Wagner Kapoor Research InstituteNorfolkVirginia23502
Chris Riebling
Alan Wagner, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St. Petersburg, FL

By research site
Retina Vitreous Associates of Florida - Saint Petersburg· St. Petersburg, FLOphthalmic Consultants of Boston· Boston, MARetina Consultants of Texas· Katy, TXWagner Kapoor Research Institute· Norfolk, VA

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