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

NCT04576689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Diabetic Macular Oedema
  • Retinal Vein Occlusion with Macular Oedema

Interventions

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Ripple Therapeutics Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Jagjit Gilhotra · Royal Adelaide Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2023-04-25
Completion
2024-03-15

Countries

  • Australia
  • Canada
  • Hong Kong
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576689 on ClinicalTrials.gov