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

RECRUITINGPhase 1Sponsored by Therini Bio Pty Ltd
Actively Recruiting
PhasePhase 1
SponsorTherini Bio Pty Ltd
Started2024-12-18
Est. completion2025-10-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06701721

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions3

DiabetesDiabetic Macular EdemaDiabetic Retinopathy

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