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

Last updated: December 17, 2024
Sponsor: Therini Bio Pty Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Macular Edema

Diabetic Macular Edema

Retina

Treatment

THN391 MAD

Clinical Study ID

NCT06701721
THN391-OPT-101
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be willing and able to understand the study procedures and the risks involved andprovide 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

Exclusion Criteria:

  • Be pregnant or breastfeeding

  • Cataract surgery or any other previous ocular surgery in the study eye within 3months before Screening

  • Any other condition except for DME that could affect interpretation of studyassessments

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: THN391 MAD
Phase: 1
Study Start date:
December 18, 2024
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Marsden Eye Specialists

    Parramatta, New South Wales 2150
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

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