A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
NCT ID: NCT06701721
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2024-12-18
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Sequential Multiple Ascending Doses
Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.
THN391 MAD
Route of administration- IVT injection
Interventions
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THN391 MAD
Route of administration- IVT injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Therini Bio Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Naor
Role: STUDY_DIRECTOR
Therini Bio, Inc.
Locations
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Marsden Eye Specialists
Parramatta, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Jennifer Arnold, Dr
Role: primary
Jagjit S Gilhotra, Prof
Role: primary
Other Identifiers
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THN391-OPT-101
Identifier Type: -
Identifier Source: org_study_id