Case Study

Full Service Management Of A Complex Global Multi-Phase Diabetic Macular Edema Study

Source: Chiltern

An adaptive design protocol incorporating an open label dose-escalation range-finding Phase I portion to confirm comparative dosing for the the multi-arm Phase II portion with combination and monotherapy treatment regimens for DME.

The Sponsor selected Chiltern to perform full services with enrollment of 260 patients at 50 centers over 12 months in North America, Europe and Israel.

The unique, highly complex protocol led to several rounds of Regulatory and Ethics inquiries and 4 substantial protocol amendments.

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