Macular Degeneration Clinical Trial
Official title:
A Phase 1 Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 in Combination With Ranibizumab in Subjects With Wet AMD
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and
pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with
and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study
will be conducted in two parts: Part 1 will comprise an open label, sequential dose
escalation and Part 2 a randomized dose expansion.
OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human
vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It
functions by binding and neutralizing the activity of vascular endothelial growth factor
(VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3.
VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating
VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage.
Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet
AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or VEGF-D
which are alternate members of the same family of molecules.
VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as
VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via
VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important role
in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™.
Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of
the VEGF family. This strategy targets functional redundancy in the VEGF pathway and
mechanisms of 'resistance' or sub-response to VEGF-A inhibition.
n/a
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