Trials / Completed
CompletedNCT04422899
Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration
A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- AiViva BioPharma, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
Detailed description
AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 \& -3); fibroblast growth factor receptors (FGFR-1, -2, -3 \& -4); and platelet-derived growth factor receptors (PDGFR-α \& β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AIV007 | intravitreal |
Timeline
- Start date
- 2020-08-28
- Primary completion
- 2021-09-29
- Completion
- 2022-02-28
- First posted
- 2020-06-09
- Last updated
- 2024-12-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04422899. Inclusion in this directory is not an endorsement.