RecruitingPhase 1Phase 2NCT05986864

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

Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Sponsor

Skyline Therapeutics (US) Inc.

Enrollment

68 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

Summary

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.

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying SKG0106 for people with neovascular age-related macular degeneration. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICSKG0106

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

Locations(9)

Retina Vitreous Associates of Florida - Saint Petersburg

St. Petersburg, Florida, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Retina Consultants of Texas

Katy, Texas, United States

Wagner Kapoor Research Institute

Norfolk, Virginia, United States

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Eye Hospital, WMU (Zhejiang Eye Hospital)

Wenzhou, Zhejiang, China

Beijing Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT05986864

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