Age-related Macular Degeneration Clinical Trial
Official title:
An Open Label, Pilot (Phase I/II), Dose-Escalation Safety and Tolerability Study of Combretastatin A4 Phosphate in Patients With Neovascular Age-Related Macular Degeneration.
The purpose of the study is assess safety, bioactivity, and maximal tolerated dose of repeated weekly intravenous infusion of combretastatin A-4 phosphate (CA4P) in patients with neovascular age-related macular degeneration
The study is designed as a single escalating dose with cohorts of five subjects. Escalation
to the next cohort was based on the presence of no more than one subject with a dose limiting
toxicity (DLT). The first cohort is to receive 27 mg/m2 intravenous infusion of of CA4P,
36mg/m2 to the second cohort, and 45mg/m2 to the third cohort. CA4P will be infused at
baseline and every week for a total of 4 doses. Follow up visits will be scheduled at week 8
and 12.
Safety data will be collected during the 12-week duration of the study and will be assessed
using the common terminology criteria of adverse events (CTCAE v3.0). Bioactivity data will
be assessed by measuring change in best corrected visual acuity, changes in central retinal
thickness as measured by Optical coherence tomography, and changes in the amount of leakage
on fluorescein angiography.
DLTs were defined as specific events that are considered to be probably or definitely related
to CA4P. Major DLTs included QTc interval ≥ 500 msec (based on measurements provided by the
core laboratory for ECG analysis), Grade-2 or greater ventricular arrhythmia, unexplained
syncope, Grade-3 or greater toxicity, delayed recovery postponing re-treatment by >14 days,
and ocular toxicity such as keratopathy, uveitis, optic neuropathy, and retinopathy, at the
discretion of the investigator.
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