Diabetic Macular Oedema Clinical Trial
Official title:
RIPPLE-1: Evaluation of Safety and Efficacy of the IBE-814 Intravitreal Implant in Patients With Diabetic Macular Oedema and Macular Oedema Due to Retinal Vein Occlusion
This trial is a phase II, multi-center, single-masked (assessors) dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients with DMO and RVO.
The study will enroll up to 50 patients (up to 50 eyes) with DMO or RVO across two treatment groups (Low Dose and High Dose). Patients will be identified and recruited through the clinic population of ophthalmology centers in Australia and New Zealand, specializing in the diagnosis and treatment of retinal diseases. All patients will be followed for a planned evaluation period of 18 months. ;
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