JRCT ID: jRCT2073250145
Registered date:23/03/2026
Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy (RGX-314 SRLTFU)
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Neovascular age-related macular degeneration |
| Date of first enrollment | 30/04/2026 |
| Target sample size | 14 |
| Countries of recruitment | United States,Japan,Puerto Rico,Japan,Canada,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Spain,Japan,United Kingdom,Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Incidence of ocular adverse events and any serious adverse events in the study eye |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 50age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Able and willing to provide written consent 2. Previously enrolled in a clinical study of RGX-314 and received a single subretinal administration of RGX-314 |
| Exclude criteria | None |
Related Information
| Primary Sponsor | Otani Tetsuya |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT03999801 |
Contact
| Public contact | |
| Name | Contact for Patients and HCP |
| Address | 3-2-1 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
| Telephone | +81-120-587-874 |
| AbbVie_JPN_info_clingov@abbvie.com | |
| Affiliation | AbbVie GK |
| Scientific contact | |
| Name | Tetsuya Otani |
| Address | 3-2-1 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023 |
| Telephone | +81-120-587-874 |
| AbbVie_JPN_info_clingov@abbvie.com | |
| Affiliation | AbbVie GK |