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Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 for Age-Related Macular Degeneration

N/A
Recruiting
Research Sponsored by Skyline Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years post study drug injection
Awards & highlights

Summary

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.

Eligible Conditions
  • Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years post study drug injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post study drug injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Secondary outcome measures
Mean change in best corrected visual acuity (BCVA) at each visit from baseline
Mean change in macular central subfield thickness (CST) at each visit from baseline
Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline

Trial Design

3Treatment groups
Experimental Treatment
Group I: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3Experimental Treatment1 Intervention
No investigational product will be administered in this study.
Group II: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2Experimental Treatment1 Intervention
No investigational product will be administered in this study.
Group III: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1Experimental Treatment1 Intervention
No investigational product will be administered in this study.

Find a Location

Who is running the clinical trial?

Skyline TherapeuticsLead Sponsor
~55 spots leftby Mar 2031