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

Recruiting now · Phase 1

Conditions studied: Diabetic Macular Edema, Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT06701721

Run by

Therini Bio Pty Ltd

People needed

21

Starts

2024-12-20

Expected to finish

2027-05-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marsden Eye Specialists — Parramatta, New South Wales, Australia (enrolling)
• South Eastern Sydney Local Health District — Sydney, New South Wales, Australia (enrolling)
• Sydney West Retina — Westmead, New South Wales, Australia (enrolling)
• Princess Alexandria Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
• Sunshine Eye Surgeons — Albans, Victoria, Australia (enrolling)
• Eye Surgery Associates Pty Ltd — Malvern, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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