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 18, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetic Retinopathy Diabetic 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

Inclusion Criteria4

Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
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 Criteria3

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

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