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Monoclonal Antibodies

SKG0106 for Age-Related Macular Degeneration

Phase 1 & 2
Recruiting
Research Sponsored by Skyline Therapeutics (US) Inc.
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 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety & efficacy of SKG0106, a drug for treating nAMD, compared to Eylea® in a double-masked study.

Who is the study for?
This trial is for individuals aged 50 or older with neovascular Age-related Macular Degeneration (nAMD). Participants must have a specific type of lesion in the eye and some fluid in the retina, with vision levels within a certain range. They cannot join if they have any active eye infections, certain types of retinal damage, recent vitreous hemorrhage, conditions that limit vision improvement, history of gene therapy or retinal detachment.
What is being tested?
The study tests SKG0106 intraocular solution's safety and effectiveness for nAMD patients. It starts with determining safe dosage levels (Phase I) and then expands to more patients to further assess its effects (Phase II), including how long it stays in the body and if it triggers immune responses.
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions related to intraocular injections such as eye irritation or inflammation, increased risk of infection inside the eye, possible allergic reactions to components of SKG0106 solution.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean change from baseline in best corrected visual acuity (BCVA) at each visit
Mean change from baseline in central subfield thickness (CST) at each visit
Mean change from baseline in patient-reported outcome (VFQ-25) scale score at each visit

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase I: Medium doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 2
Group II: Phase I: Low doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 1
Group III: Phase I: High doseExperimental Treatment1 Intervention
SKG0106 One-Time Intraocular Injection Dose Level 3

Find a Location

Who is running the clinical trial?

Skyline Therapeutics (US) Inc.Lead Sponsor

Media Library

SKG0106 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05986864 — Phase 1 & 2
Macular Degeneration Research Study Groups: Phase I: Medium dose, Phase I: Low dose, Phase I: High dose
Macular Degeneration Clinical Trial 2023: SKG0106 Highlights & Side Effects. Trial Name: NCT05986864 — Phase 1 & 2
SKG0106 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05986864 — Phase 1 & 2
~40 spots leftby Jan 2026
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