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RECRUITINGPhase 1INTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Be willing and able to understand the study procedures and the risks involved and provide written willing to sign a consent form before the first study-related activity - 18 to 80 years of age (inclusive at the time of willing to sign a consent form). - Diagnosis of Diabetic Macular Edema (DME) - Vision loss in the study eye Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

THN391 MAD

Route of administration- IVT injection

Locations (2)

Marsden Eye Specialists
Parramatta, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia