Case Studies >>
India Support for a Multinational Study for a Novel Ocular Implant (Artificial Endothelial Layer)

An innovative medical device company based in Israel developed a unique ocular implant with an artificial endothelial layer to treat patients with corneal edema caused by a dysfunctional endothelial layer, resulting in poor vision quality.
Nextvel was involved in the early-stage clinical development and pilot clinical investigation. When the Phase 2 study was conducted across multiple countries, Nextvel provided regulatory and clinical trial management support for India. Nextvel facilitated patient enrolment within the stipulated time frame, achieving the fastest enrolment rate among participating countries. The one-year follow-up study had a 90% subject retention rate in India at the end of 12 months follow-up period. Nextvel used the latest EDC and Document Management System for seamless data management for this project.
The ocular implant received marketing approval in India, with Nextvel facilitating the necessary regulatory approvals for registration. Recognizing Nextvel’ s expertise, the Israeli company appointed Nextvel as their Indian Agent for this product.
This innovative ocular implant offers hope for improved vision to patients with corneal edema in India and worldwide. Nextvel’s involvement in the multi-national study and their role as the Indian Agent underscore their commitment to advancing healthcare through cutting-edge innovations and global collaborations.
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