Myopia, Pathological Clinical Trial
Official title:
A Phase-3, Multi-center, Randomized, Double-masked, Sham-controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Subjects With Choroidal Neovascularization Secondary to Pathologic Myopia
VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to
choroidal neovascularization secondary to pathologic myopia. This will be a
placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye
into the affected eye (and repeated injections if required), and 1 out of 4 patients will
receive a sham injection requiring no needle stick, but making the patient unaware of
whether or not he received active treatment.
Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham
patients may receive active treatment.
Total duration of the study will be 48 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment