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

Phase 1

Recruiting

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Drug: THN391 MAD

• Registration Number: NCT06701721
• Lead Sponsor: Therini Bio Pty Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Study Start: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-10-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sequential Multiple Ascending Doses	THN391 MAD	Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 16 weeks following first dose administration	Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity	Up to 16 weeks following first dose administration	Measured using ETDRS method
Change in Retinal Edema	Up to 16 weeks following first dose administration	Measured with Optical Coherence Tomography (OCT)

Trial Locations

Locations (2)

Marsden Eye Specialists; 🇦🇺 Parramatta, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia