Testing THN391 for Diabetic Macular Edema
Official title: 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.
Run by Therini Bio, Inc. · NCT06701721 · Data updated 2026-11-12
This study is testing a new drug called THN391 to see if it can safely help people with diabetic macular edema caused by diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | Therini Bio, Inc. Industry-sponsored |
| Locations | 10 sites (Parramatta, New South Wales and 9 other locations) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT06701721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with a diagnosis of diabetic macular edema and vision loss in the study eye.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have had recent ocular surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and preliminary efficacy of THN391, administered as a monotherapy, in patients suffering from diabetic macular edema (DME) due to non-proliferative diabetic retinopathy. It is an open-label, multiple ascending dose study that will enroll approximately 21 participants across three sequential dose-escalating cohorts. Participants will receive three monthly administrations of THN391, allowing researchers to assess the drug's effects and safety profile.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients with diabetic macular edema.
How similar studies have gone: While this approach is novel, similar studies targeting diabetic macular edema have shown promising results in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Marsden Eye Specialists
Parramatta, New South Wales, Australia Recruiting -
South Eastern Sydney Local Health District
Sydney, New South Wales, Australia Recruiting -
Royal Adelaide Hospital
Adelaide, South Australia, Australia Recruiting -
Sunshine Eye Surgeons
Albans, Victoria, Australia Recruiting -
Eye Surgery Associates Pty Ltd
Malvern, Victoria, Australia Recruiting -
Ltd Akhali Mzera
Tbilisi, Georgia Recruiting
Show 4 more locations
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LLC Caucasus Medical Center
Tbilisi, Georgia Recruiting -
Davinci
Tbilisi, Georgia Recruiting -
Sydney West Retina
Westmead, New South Wales, Australia Terminated -
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia Terminated
Study contacts
- Study coordinator: Liza Wallace
- Email: lwallace@therinibio.com
- Phone: +1 (925) 819-1952
Similar studies
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-
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-
Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy
This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.
-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.