drugset / Trial / NCT03585556
AAVCAGsCD59 for the Treatment of Wet AMD
NaSingle-groupOpen-labelTreatment
Summary
Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7. Patients will be followed monthly through Month 12 and receive an intravitreal anti-VEGF injection as needed based on an increase in central subfoveal thickness (CST) of \>50 micrometers on OCT from Day 0, new subretinal hemorrhage on clinical exam, and/or loss of 10 or more ETDRS letters from the previous month exam.
Timeline
- Start
- 2018-09-13
- Primary completion
- 2020-01-29
- Completion
- 2022-01-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AAVCAGsCD59 | Gene therapy (AAV / viral vector) | 3.56e+11 vg | Intravitreal |
| Subject | AAVCAGsCD59 | Gene therapy (AAV / viral vector) | 1.071e+12 vg | Intravitreal |
| Background | Aflibercept | Protein / enzyme biologic | — | Intravitreal |
| Background | Bevacizumab | Monoclonal antibody | — | Intravitreal |
| Background | Prednisolone | Other / unclassified | — | Oral |
| Background | Ranibizumab | Monoclonal antibody | — | Intravitreal |