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
| Name | Class |
|---|---|
| Eye & ENT Hospital of Fudan University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
A clinical trial of gene therapy for patients with X-linked retinitis pigmentosa (XLRP).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose FT-002 | Experimental | Intraocular injection of a single low dose of FT-002 |
|
| Intermediate dose FT-002 | Experimental | Intraocular injection of a single Intermediate dose of FT-002 |
|
| High dose FT-002 | Experimental | Intraocular injection of a single High dose of FT-002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT-002 | Genetic | Comparison of different dosages of FT-002 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | Number and proportion of Adverse Events | from FT-002 administration through up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual function | Change in retinal function as assessed by mean retinal sensitivity within the 30-degree visual field | from FT-002 administration through up to 1 years |
| Change in retinal structure as assessed by Optical Coherence Tomography |
Not provided
Inclusion Criteria:
1.Subjects that are willing and able to follow study procedures; 2.Males aged 8-45 years old at the time of signing the Informed Consent Form; 4.Subjects who are confirmed with variants of RPGR ;
Exclusion Criteria:
1.Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyan Li | Contact | +86-021-58206061 | xinyan.li@fronteratherapeutics.com | |
| Minghui Xue | Contact | +86-021-58206061 | minghui.xue@fronteratherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Gezhi Xu | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Ruifang Sui | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Researchers qualified can request the dataset, including de-identified individual subject data.
Not provided
Not provided
Not provided
Not provided
Not provided
X-linked retinitis pigmentosa patients
Not provided
Not provided
Not provided
Not provided
Change in Outer Nuclear Layer Thickness from baseline as assessed by Optical Coherence Tomography
| from FT-002 administration through up to 1 years |
| Eye & ENT hospital of Fudan university | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|