A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Skyline Therapeutics
Study ID
NCT06346600
Status
Recruiting
Apply to this trial

Conditions

  • Neovascular (Wet) Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • SKG0106 — GENETIC
    Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.

Study Details

This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.

Key Dates

Start date
Apr 2, 2024
Status verified
Apr 2024
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
83 participants (estimated)

Arms

  • Arm: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1
    No investigational product will be administered in this study.
  • Arm: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2
    No investigational product will be administered in this study.
  • Arm: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3
    No investigational product will be administered in this study.

Primary Outcome Measure

Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: 5 years post study drug injection ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Consultants of TexasKatyTexas77494-
Wagner Macula & Retina CenterNorfolkVirginia23502-

Find similar trials in Boston, MA

By research site
Ophthalmic Consultants of Boston· Boston, MARetina Consultants of Texas· Katy, TXWagner Macula & Retina Center· Norfolk, VA

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