12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)

Phase 2 Terminated 19 enrolled GlaxoSmithKline

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD.

Timeline

Start: 2011-07-07
Primary completion: 2012-04-16
Completion: 2012-04-16

Outcome

Missed primary endpoint

Stopped: “Lack of efficacy identified during a preliminary analysis”

paper there were no meaningful changes from baseline in the mean central retinal thickness (37.9 μm) or best-corrected visual acuity (0.1 letters) (primary endpoint) PMID 24896137 ↗

paper pazopanib instilled 4 times daily as monothereapy did not seem to improve the best-corrected visual acuity or decrease the central retinal thickness. PMID 24896137 ↗

Publications

Singh R, Wurzelmann JI, Ye L, Henderson L, Hossain M, Trivedi T, Kelly DS. Clinical evaluation of pazopanib eye drops in healthy subjects and in subjects with neovascular age-related macular degeneration. Retina. 2014 Sep;34(9):1787-95. doi: 10.1097/IAE.0000000000000179.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pazopanib	Small molecule	10 mg/ml	Topical