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RecruitingPhase 1NCT06701721

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

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.

Sponsor

Therini Bio Pty Ltd

Enrollment

21 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetic RetinopathyDiabetic Macular Edema

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called THN391 MAD for people with diabetic macular edema and diabetic retinopathy. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTHN391

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

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NCT06701721

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