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A Study to Evaluate the Safety and Tolerability of EXN407

NCT04565756 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-09

Study results available
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Summary

This first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved Diabetic Macular Oedema (DMO), with Centre-subfield macular thickness (CMT) between 280-420 µm and Best corrected visual acuity (BCVA) better than or equal to 69 ETDRS score (approximate Snellen equivalent 20/40 (6/12 letters) in the study eye, which is considered secondary to diabetes mellitus.

This study will provide a basis for further clinical development of EXN407 ophthalmic solution.

Conditions

Interventions

DRUG

EXN407

EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Exonate Limited

    lead INDUSTRY

Principal Investigators

  • Mark Gillies, Prof · Sydney Eye Hospital/Save Sight Institution

  • Andrew Chang, A/Prof · Sydney Retina Clinic & Day Surgery

  • Sanjeewa Wickremasinghe,, Prof · Centre for Eye Research Australia (CERA)

  • Fred Chen, Dr · Lions Eye Institute

  • Jolly Gilhotra, A/Prof · Adelaide Eye and Retina Centre

  • Wilson Heriot, A/Prof · ZAVe Clinical Research Management - Retinology Institute

  • Hemal Mehta, Dr · Strathfield Retina Clinic

  • Peter Davies, Dr · Newcastle Eye Hospital Foundation

  • Rohan Merani, Dr · Macquarie University

  • Helene Cass, Dr · Marsden Eye Specialists

  • Lily Ooi · Princess Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2022-10-25
Completion
2022-11-29

Countries

  • Australia

Study Locations

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Entities

Diseases

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 NCT04565756 on ClinicalTrials.gov