A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

December 17, 2024 updated by: Therini Bio Pty Ltd

A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia, 2150
        • Recruiting
        • Marsden Eye Specialists
        • Principal Investigator:
          • Jennifer Arnold
        • Contact:
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Not yet recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Jagjit Gilhotra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  • 18 to 80 years of age (inclusive at the time of informed consent).
  • Diagnosis of Diabetic Macular Edema (DME)
  • Vision loss in the study eye

Exclusion Criteria:

  • Be pregnant or breastfeeding
  • Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening
  • Any other condition except for DME that could affect interpretation of study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential Multiple Ascending Doses
Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.
Drug: THN391 MAD
Route of administration- IVT injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 16 weeks following first dose administration
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Up to 16 weeks following first dose administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Acuity
Time Frame: Up to 16 weeks following first dose administration
Measured using ETDRS method
Up to 16 weeks following first dose administration
Change in Retinal Edema
Time Frame: Up to 16 weeks following first dose administration
Measured with Optical Coherence Tomography (OCT)
Up to 16 weeks following first dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Therini Bio Pty Ltd

Investigators

  • Study Director: Joel Naor, Therini Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 18, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THN391-OPT-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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