A Phase 1 interventional study of THN391 in Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Therini Bio Pty Ltd. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Therini Bio Pty Ltd · Phase 1, Interventional, and Treatment
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Among 17 studies in Diabetic Retinopathy with a site in Australia — 4 open to participants now, 6 under way, 2 of them phase 3. Diabetic Retinopathy · Australia.
Among the 17 studies in Diabetic Retinopathy with a site in Australia, this one is the 14th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2024, is the only one in phase 1, and was the 13th registered.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
Browse Diabetic Retinopathy studies →4 of the 17 studies in Diabetic Retinopathy with a site in Australia are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in Australia, United States, Argentina and 1 more country
Ages 18+
Center for Eye Research Australia · Sites in Australia
Ages 18+ · Healthy volunteers
Center for Eye Research Australia · Sites in Australia
Ages 18+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 92 Diabetic Retinopathy studies recruiting now, 60 (65%) set no upper age limit and 10 (11%) stop at 75 or younger; 8 take children under 18; 29 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 5 · Phase 4 2
First in 1999; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 21 is below the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.
Median enrollment 81 across the 16 interventional studies, 45 across the 1 observational. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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9 of 17 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Therini Bio Pty Ltd as lead sponsor.
Therini Bio Pty Ltd has 1 study filed under Diabetic Retinopathy — fewer than ten, so there is no comparison to draw.
2 of the studies in Diabetic Retinopathy with a site in Australia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06701721Therini Bio Pty LtdA Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy. | 2027-03-31 |
| NCT06770933Vantage Biosciences LtdA Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 | 2027-07 |
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Among the 17 studies in Diabetic Retinopathy with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
THN 391 (low dosage), IVT injection
Drug: THN391
THN 391 (medium dosage), IVT injection
Drug: THN391
THN 391 (high dosage), IVT injection
Drug: THN391
THN391, IVT injection, 3\*Q4W (every 4 weeks)
Adverse Events
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Time frame: Up to 16 weeks following first dose administration
Change in Visual Acuity
Measured using ETDRS method
Time frame: Up to 16 weeks following first dose administration
Change in Retinal Edema
Measured with Optical Coherence Tomography (OCT)
Time frame: Up to 16 weeks following first dose administration
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Mar 2027, 27 months after the start.
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