Choroidal Neovascularization Clinical Trial
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 Neovascularization Secondary to Age-Related Macular Degeneration
The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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