NCT04576689

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ripple Therapeutics Pty Ltd · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will enroll up to 60 patients (up to 60 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, New Zealand, Hong Kong, and Canada specializing in the diagnosis and treatment of retinal diseases. All patients will be followed for a planned evaluation period of 18 months.

Conditions

• Diabetic Macular Oedema
• Retinal Vein Occlusion with Macular Oedema

Interventions

Type	Name	Description
DRUG	IBE-814 70ug	At least 10 and up to 33 participants will receive one (1) IBE-814. Route of administration: intravitreal injection.
DRUG	IBE-814 140ug	Up to 27 participants will receive two (2) IBE-814. Route of administration: intravitreal injection.

Timeline

• Start date: 2020-10-30
• Primary completion: 2023-04-25
• Completion: 2024-03-15
• First posted: 2020-10-06
• Last updated: 2025-03-21

Locations

21 sites across 4 countries: Australia, Canada, Hong Kong, New Zealand