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.
1 other identifier
interventional
21
1 country
7
Brief Summary
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2024
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
December 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
July 2, 2026
June 1, 2026
2.3 years
November 19, 2024
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Up to 16 weeks following first dose administration
Secondary Outcomes (2)
Change in Visual Acuity
Up to 16 weeks following first dose administration
Change in Retinal Edema
Up to 16 weeks following first dose administration
Study Arms (3)
Cohort 1
EXPERIMENTALTHN 391 (low dosage), IVT injection
Cohort 2
EXPERIMENTALTHN 391 (medium dosage), IVT injection
Cohort 3
EXPERIMENTALTHN 391 (high dosage), IVT injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Therini Bio Pty Ltdlead
- Therini Bio, Inc.collaborator
Study Sites (7)
Marsden Eye Specialists
Parramatta, New South Wales, 2150, Australia
South Eastern Sydney Local Health District
Sydney, New South Wales, 2000, Australia
Sydney West Retina
Westmead, New South Wales, 2145, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Sunshine Eye Surgeons
Albans, Victoria, 3021, Australia
Eye Surgery Associates Pty Ltd
Malvern, Victoria, 3144, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joel Naor
Therini Bio, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2024
First Posted
November 22, 2024
Study Start
December 20, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share