At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating VEGF Trap-Eye (BAY86-5321) and No Drug for Myopia, Pathological. Completed, enrolled 122 participants across 20 sites in 5 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed
Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea