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
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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Interventions
DRUGTHN391 MAD
Route of administration- IVT injection
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06701721
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