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A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Sponsor: Therini Bio Pty Ltd
Summary
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Official 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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2024-12-20
Completion Date
2027-05-31
Last Updated
2026-07-02
Healthy Volunteers
No
Interventions
THN391
THN391, IVT injection, 3\*Q4W (every 4 weeks)
Locations (7)
Marsden Eye Specialists
Parramatta, New South Wales, Australia
South Eastern Sydney Local Health District
Sydney, New South Wales, Australia
Sydney West Retina
Westmead, New South Wales, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Sunshine Eye Surgeons
Albans, Victoria, Australia
Eye Surgery Associates Pty Ltd
Malvern, Victoria, Australia