Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1 | No investigational product will be administered in this study. |
| |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2 | No investigational product will be administered in this study. |
| |
| Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3 | No investigational product will be administered in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKG0106 | Genetic | Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) | 5 years post study drug injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years post study drug injection |
| Mean change in macular central subfield thickness (CST) at each visit from baseline |
Not provided
Inclusion Criteria:
Subjects who only meet all of the following criteria are eligible for this study:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqin Wang | Contact | +86 18616737445 | yongqin.wang@skytx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Not yet recruiting | Boston | Massachusetts | 02114 | United States | |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit. |
| 5 years post study drug injection |
| 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. | 5 years post study drug injection |
| Retina Consultants of Texas |
| Not yet recruiting |
| Katy |
| Texas |
| 77494 |
| United States |
| Wagner Macula & Retina Center | Not yet recruiting | Norfolk | Virginia | 23502 | United States |
| The Second Hospital Of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
| Eye Hospital, WMU (Zhejiang Eye Hospital) | Not yet recruiting | Wenzhou | Zhejiang | China |
| Beijing Hospital | Not yet recruiting | Beijing | China |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| EYE & ENT Hospital of Fudan University | Recruiting | Shanghai | China |
| Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine | Not yet recruiting | Shanghai | China |