# Targeted Intraceptors for Macular Degeneration

> **NIH NIH R44** · IVEENA DELIVERY SYSTEMS, INC. · 2020 · $1,002,479

## Abstract

Project Summary
Age-related Macular Degeneration (AMD) is the leading cause of blindness in US. It affects over 25% of the
people by the age 80. An estimated 25 million people are afflicted with AMD worldwide. Neovascular or “wet”
AMD, which affects 10%–15% of AMD patients, is a rapid form of the disease and progresses to blindness if left
untreated. Histopathologically, the disease involves lesions in the Bruch's membrane and or retinal pigment
epithelium (RPE) with choroidal neovascularization (CNV; abnormal blood vessels growth from choroid into the
retina). As a mediator of angiogenesis and vascular permeability, vascular endothelial growth factor (VEGF)
plays a key role in the onset of CNV. Current therapy for wet AMD consists of monthly or bimonthly intravitreal
administration of anti-VEGF drugs that sequester VEGF-A extracellularly. This therapeutic approach
substantially improves near-term prognosis, but prognosis beyond 2 years of treatment is poor, with steady
decline in visual acuity observed to 7 years of follow-up in several clinical trials. Long-term rates of fibrosis &
geographic atrophy are higher with chronic anti-VEGF therapy than in historic cohorts of AMD patients. More
than half of treated eyes show ongoing CNV leakage, fibrotic scarring, and/or geographic atrophy. A significant
number of patients receiving anti-VEGF therapy do not experience substantial visual improvement, and a third
of treated eyes continue to lose visual acuity and progress to legal blindness. Furthermore, periodic intravitreal
injections imposes significant economic burdens on patients and practices as well as potential risks of bleeding,
infection, traumatic injury, and retinal detachment. Our goal is to develop a less invasive therapeutic
strategy, which improves vision and halts CNV with an acceptable safety profile and presents reduced
risk.
Using Phase 1 funding support, we established the dose response and efficacy of intravenously administered
Flt23k intraceptor on regression of laser-induced CNV in mice; and determined the safety of intravenously
administered Flt23k intraceptor nanoparticles in mice. In Phase II, we propose to assess safety in rabbits and
the efficacy of this novel AMD therapy in a non-human primate (NHP, African green monkeys) laser induced
CNV model under GLP conditions. We will also pursue appropriate regulatory approvals for this transformative
approach of treating AMD. The impact of our Phase II project includes identifying a safe and efficacious dose
that is feasible for manufacturing under GMP conditions to test in humans in a Phase 1 clinical trial. We will
accomplish the following specific aims:
Aim 1: To establish pharmacokinetics and safety of intravenously administered Flt23k intraceptor
nanoparticles in rabbits using GLP conditions.
Aim 2: To establish the efficacy of intravenously administered Flt23k intraceptor nanoparticles on
regression of laser-induced CNV in non-human primates.

## Key facts

- **NIH application ID:** 10020985
- **Project number:** 5R44EY024501-03
- **Recipient organization:** IVEENA DELIVERY SYSTEMS, INC.
- **Principal Investigator:** Randon Michael Burr
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,002,479
- **Award type:** 5
- **Project period:** 2015-08-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020985

## Citation

> US National Institutes of Health, RePORTER application 10020985, Targeted Intraceptors for Macular Degeneration (5R44EY024501-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10020985. Licensed CC0.

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