Long-term follow-up for patients with wet age-related macular degeneration receiving SKG0106
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)
This study is testing how well and safely the treatment SKG0106 works for people with wet age-related macular degeneration over a long period after their last injection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 83 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Skyline Therapeutics Industry-sponsored |
| Locations | 10 sites (Boston, Massachusetts and 9 other locations) |
| Trial ID | NCT06346600 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term safety and efficacy of SKG0106 in patients with neovascular (wet) age-related macular degeneration (nAMD) who have previously participated in related clinical studies. Participants will be monitored for up to five years following their last injection of SKG0106 to assess ongoing treatment effects. The study aims to gather data on the long-term outcomes of this treatment in a multicenter setting.
Who should consider this trial
Good fit: Ideal candidates are patients who have previously received SKG0106 injections and completed the related clinical studies.
Not a fit: Patients who have not received SKG0106 or those deemed unsuitable by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of SKG0106 for patients with nAMD.
How similar studies have performed: Other studies evaluating long-term outcomes of treatments for nAMD have shown promising results, suggesting that this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 9 other locations
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (Not_yet_recruiting)
- Retina Consultants of Texas — Katy, Texas, United States (Not_yet_recruiting)
- Wagner Macula & Retina Center — Norfolk, Virginia, United States (Not_yet_recruiting)
- The Second Hospital Of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Eye Hospital, WMU (Zhejiang Eye Hospital) — Wenzhou, Zhejiang, China (Not_yet_recruiting)
- Beijing Hospital — Beijing, China (Not_yet_recruiting)
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
- EYE & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
- Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine — Shanghai, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yongqin Wang
- Email: yongqin.wang@skytx.com
- Phone: +86 18616737445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.