VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2013-02
- Completion
- 2013-08
Outcome
Met primary endpoint
registry Aflibercept Injection First, Then Aflibercept or Sham vs Sham Treatment First, Then Aflibercept Injection or Sham; p <0.0001 NCT01249664 ↗
registry Difference in least square means 14.1 (95% CI 10.8 to 17.4) NCT01249664 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | — | Intravitreal |