May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
Phase II Clinical Trial of Intravenous Combretastatin A4 Phosphate in Patients With Subfoveal Choroidal Neovascular Membranes (CNV) in Pathologic Myopia
Author Affiliations & Notes
  • T. P. Wong
    Vitreoretinal Consultants, Houston, Texas
  • D. M. Brown
    Vitreoretinal Consultants, Houston, Texas
  • M. S. Benz
    Vitreoretinal Consultants, Houston, Texas
  • Footnotes
    Commercial Relationships T.P. Wong, Acuity, Alimera, Allergan, Eli Lilly, Eyetech, Genentech, Novartis, Oxygene, Pfizer, Regeneron, F; Novartis, C; D.M. Brown, Acuity, Alimera, Allergan, Eli Lilly, Eyetech, Genentech, Novartis, Oygene, Pfizer, Regeneron, F; Alcon, Allergan, Eyetech, Genentech, Pfizer, Novartis, C; M.S. Benz, Acuity, Alimera, Allergan, Eli Lilly, Eyetech, Genentech, Novartis, Oygene, Pfizer, Regeneron, F; Allergan, Eyetech, Genentech, Novartis, Regeneron, C.
  • Footnotes
    Support Oygene, Inc. Waltham MA
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1457. doi:
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    • Get Citation

      T. P. Wong, D. M. Brown, M. S. Benz; Phase II Clinical Trial of Intravenous Combretastatin A4 Phosphate in Patients With Subfoveal Choroidal Neovascular Membranes (CNV) in Pathologic Myopia. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1457.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose:
 

To investigate/evaluate the safety & efficacy of CombretastatinA4 Phosphate (CA4P), a vascular disrupting agent, for treatingsubfoveal CNV in subjects with pathologic myopia.

 
Methods:
 

This Phase II, parallel group, dose-ranging, double masked studyconducted in 9 centers in North America, Taiwan and Russia enrolledsubjects into one of three treatment groups (27, 36, or 45 mg/m2).Subjects received two IV infusions of CA4P one week apart perprotocol. During follow-up visits, subjects could receive upto three additional re-treatments. Primary efficacy endpointis best corrected ETDRS at 3 months with less than 3 lines ofvision loss. Safety variables include vital signs, physicalexams, laboratory tests, slit-lamp biomicroscopy, dilated fundusexams, fundus photography, ECGs, and adverse events (AEs).

 
Results:
 

By June 2006, 21 subjects (7 subjects into each dose group)were enrolled at 9 study centers. Of these, 13 completed theETDRS 3 month assessment (27 mg/m2 n=5; 36 mg/m2 n= 4; 45 mg/m2n=4). The primary endpoint data suggests a possible dose responserelationship (Table 1). Vision was maintained in all patientsin all dose groups. Trends in FA and OCT data were not observedand are inconclusive at this time.Table 1: Best corrected visualacuity results at 3 months by dose of CA4PTable 2: AE’s Possibly related to StudyDrug by Severity 

 

 
Conclusions:
 

Preliminary data suggests a beneficial effect of CA4P’snovel mechanism of action as a vascular disrupting agent forCNV, and supports further development of oral and topical formsof administration for diseases associated with CNV. Final datafor all patients will be available and presented in May 2007.

 
Clinical Trial:
 

www.clinicaltrials.gov ISRCTN85551991

 
Keywords: choroid: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 
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