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

ConditionNeovascular (Wet) Age-related Macular Degeneration
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorSkyline Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;

Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study

Disqualifiers

Subjects who are judged by the investigator unsuitable for this study

Trial population

It is expected that a total of 83 study subjects from parent study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • SKG0106

    Genetic

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

Treatment groups

83 Participants
are divided into 3 treatment groups
Group A: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 11 intervention
Group B: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 21 intervention
Group C: Long-term Follow-Up of Participants exposed to SKG0106 Dose level 31 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Mean change in best corrected visual acuity (BCVA) at each visit from baseline

BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at each visit.

Time frame
5 years post study drug injection
2

Mean change in macular central subfield thickness (CST) at each visit from baseline

Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit.

Time frame
5 years post study drug injection
3

Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline

Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.

Time frame
5 years post study drug injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Skyline Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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