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

NCT06701721 · tracked via the Priya Life Science Australia tracker

Sponsor

Therini Bio Pty Ltd

Phase

Phase 1

Started

2024-12-20

Last updated

2026-09-21

Condition(s) studied

Diabetic Macular EdemaDiabetic Retinopathy

Investigational drug(s) / intervention(s)

THN391 →

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

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (10)

Facility	City	Region	Status
Marsden Eye Specialists	Parramatta	New South Wales	Recruiting
South Eastern Sydney Local Health District	Sydney	New South Wales	Recruiting
Sydney West Retina	Westmead	New South Wales	Terminated
Princess Alexandria Hospital	Woolloongabba	Queensland	Terminated
Royal Adelaide Hospital	Adelaide	South Australia	Recruiting
Sunshine Eye Surgeons	Albans	Victoria	Recruiting
Eye Surgery Associates Pty Ltd	Malvern	Victoria	Recruiting
Ltd Akhali Mzera	Tbilisi	Georgia	Recruiting
LLC Caucasus Medical Center	Tbilisi	Georgia	Recruiting
Davinci	Tbilisi	Georgia	Recruiting

Other trials for the same condition

Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial Active, not recruiting

A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 Recruiting

A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004) Recruiting

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products Active, not recruiting

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye. Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06701721 on ClinicalTrials.gov ↗ ← All trials in Australia