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NCT Number: NCT06701721

A Study 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.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Marsden Eye Specialists, Parramatta, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THN391

Drug

THN391, IVT injection, 3*Q4W (every 4 weeks)

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Visual Acuity

    Time frame: Up to 16 weeks following first dose administration

    Measured using ETDRS method

  2. Change in Retinal Edema

    Time frame: Up to 16 weeks following first dose administration

    Measured with Optical Coherence Tomography (OCT)

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Naor

CONTACT

[email protected]

+1 (510) 364-2776

Liza Wallace

CONTACT

[email protected]

+1 (925) 819-1952

Sponsors and collaborators

Lead sponsor

Therini Bio Pty Ltd

Industry

Collaborators

  • Therini Bio, Inc.

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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