NCT05698329

Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 in Subjects with Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: AiViva BioPharma, Inc. · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

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). AiViva BioPharma, Inc. (AiViva) has developed a novel, thermoresponsive gel suspension of AIV007 for periocular administration to form a durable depot. This monotherapy is in development for the treatment of retinal and choroidal vascular disease (i.e., neovascular age-related macular degeneration (nAMD) \& diabetic macular edema (DME)). For preclinical and clinical (AIV007-E02) studies using periocular administration, AIV007 is injected outside the eyeball and the depot forms a soft mass, referred to as posterior juxtascleral depot (PJD) placement.

Conditions

• Neovascular Age-related Macular Degeneration
• Diabetic Macular Edema
• Macular Edema

Interventions

Type	Name	Description
DRUG	AIV007	Periocular injection

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-03-03
• Completion: 2025-04-01
• First posted: 2023-01-26
• Last updated: 2025-03-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study