NCT06701721 A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
| NCT ID | NCT06701721 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Therini Bio Pty Ltd |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 21 participants in total. It began in 2024-12-20 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Joel Naor
STUDY DIRECTOR
Therini Bio, Inc.
Frequently Asked Questions
Who can join the NCT06701721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06701721 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06701721 currently recruiting?
Yes, NCT06701721 is actively recruiting participants. Contact the research team at lwallace@therinibio.com for enrollment information.
Where is the NCT06701721 trial being conducted?
This trial is being conducted at Parramatta, Australia, Sydney, Australia, Westmead, Australia, Woolloongabba, Australia and 3 additional locations.
Who is sponsoring the NCT06701721 clinical trial?
NCT06701721 is sponsored by Therini Bio Pty Ltd. The principal investigator is Joel Naor at Therini Bio, Inc.. The trial plans to enroll 21 participants.