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

NCT ID: NCT06346600

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-02

Study Completion Date

2031-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neovascular (Wet) Age-related Macular Degeneration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1

No investigational product will be administered in this study.

SKG0106

Intervention Type GENETIC

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

Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2

No investigational product will be administered in this study.

SKG0106

Intervention Type GENETIC

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

Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3

No investigational product will be administered in this study.

SKG0106

Intervention Type GENETIC

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

Interventions

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SKG0106

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

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

Subjects who only meet all of the following criteria are eligible for this study:

* 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

Exclusion Criteria

* Subjects who are judged by the investigator unsuitable for this study
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Skyline Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Retina Consultants of Texas

Katy, Texas, United States

Site Status NOT_YET_RECRUITING

Wagner Macula & Retina Center

Norfolk, Virginia, United States

Site Status NOT_YET_RECRUITING

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Eye Hospital, WMU (Zhejiang Eye Hospital)

Wenzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Beijing Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

EYE & ENT Hospital of Fudan University

Shanghai, , China

Site Status RECRUITING

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine

Shanghai, , China

Site Status NOT_YET_RECRUITING

Countries

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United States China

Central Contacts

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Yongqin Wang

Role: CONTACT

+86 18616737445

Other Identifiers

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SKG0106-LF

Identifier Type: -

Identifier Source: org_study_id

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