Clinical Trial: Safety and Efficacy Study of Combretastatin A4 Phosphate to Treat Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Dose Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of Combretastatin A4 Phosphate for Treating Subfoveal Choroidal Neovascularization in Subjects With Pathologic Myopia

Brief Summary: The objectives of this study are to evaluate the safety and efficacy of 3 dose groups (27, 36 and 45 mg/m2) of Combretastatin A-4 Phosphate for the treatment of subfoveal choroidal neovascularization in subjects with pathologic myopia.

Detailed Summary:
Sponsor: Mateon Therapeutics

Current Primary Outcome:

  • Visual acuity line change from baseline at 3-month following [ Time Frame: from baseline to 3 months ]
  • Visual acuity response category at 3-month follow-up [ Time Frame: from baseline to 3 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual acuity line change from baseline at 1 month follow-up [ Time Frame: from baseline to 1 month ]
  • Visual acuity response category at 1 month follow-up [ Time Frame: from baseline to 1 month ]
  • Number of patients with treatment emergent adverse events [ Time Frame: from first dose of study drug to 30 days after last dose of study drug ]


Original Secondary Outcome: Same as current

Information By: Mateon Therapeutics

Dates:
Date Received: August 22, 2011
Date Started: March 2005
Date Completion:
Last Updated: October 28, 2011
Last Verified: October 2011