Clinical Trial: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase I Study of the Inhibition of Platelet Derived Growth Factor Using Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularizatio

Brief Summary: The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization.

Detailed Summary:

This is an open-label dose escalating study (n=15) to evaluate the safety and tolerability of the addition of imatinib mesylate to the Lucentis treatment regime over a 6 month period in patients with newly diagnosed choroidal neovascularization:

  • 5 patients will be treated with 4 weeks of imatinib mesylate 400mg per day (the lowest typical starting dose) to be started concurrently with ranibizumab (Lucentis) 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.
  • If imatinib mesylate is safely tolerated for the first 4 weeks, the following set of 5 patients will be treated with 6 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.
  • If imatinib mesylate is safely tolerated for the first 6 weeks, the following set of 5 patients will be treated with 8 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 0.5mg intravitreal injection. The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis.

Sponsor: Vitreous -Retina- Macula Consultants of New York

Current Primary Outcome: To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in combination with a daily pill of 400mg of Imatinib Mesylate in the treatment of choroidal neovascularization secondary to age-related macular degeneration

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6.
  • Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 3 and 6
  • Change in central retinal thickness as measured by OCT at months 3 and 6 compared to baseline
  • Proportion of subjects gaining ≥ 30 letters as measured by ETDRS visual refraction at month 3 and 6
  • Change in leakage area seen during fluorescein angiography at 3 and 6 months as compared with baseline


Original Secondary Outcome: Same as current

Information By: Vitreous -Retina- Macula Consultants of New York

Dates:
Date Received: November 22, 2006
Date Started: November 2006
Date Completion:
Last Updated: December 30, 2015
Last Verified: December 2015