NCT01570790

Combretastatin A4 Phosphate in Patients With Neovascular Age-Related Macular Degeneration

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Combretastatin A4 Phosphate
• Age-related Macular Degeneration
• AMD
• CNV
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Combretastatin A-4 phosphate	27 mg/m2 CA4P IV infusion at baseline and every week for 4 doses
DRUG	Combretastatin A-4 Phosphate	36 mg/m2 CA4P IV infusion at baseline and every week for 4 doses
DRUG	Combretastatin A-4 Phosphate	45 mg/m2 CA4P IV infusion at baseline and every week for 4 doses

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2012-04-04
• Last updated: 2017-12-06

Locations

1 site across 1 country: United States