Testing THN391 for Diabetic Macular Edema
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.
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 |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Therini Bio, Inc. Industry-sponsored |
| Locations | 2 sites (Parramatta, New South Wales and 1 other locations) |
| Trial ID | NCT06701721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of diabetic macular edema and vision loss in the study eye.
Not a fit: Patients who are pregnant, breastfeeding, or have had recent ocular surgery may not benefit from this study.
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 performed: While this approach is novel, similar studies targeting diabetic macular edema have shown promising results in the past.
Eligibility criteria
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 this trial is running
Parramatta, New South Wales and 1 other locations
- Marsden Eye Specialists — Parramatta, New South Wales, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Liza Wallace
- Email: lwallace@therinibio.com
- Phone: +1 (925) 819-1952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.