NCT06701721RecruitingPhase 1
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.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 20 Dec 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Therini Bio Pty Ltd
- Diseases
- Diabetic eye disease
- NCT number
- NCT06701721
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 20 Dec 2024 to the primary completion date, 31 Mar 2027
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening
Other illness
- Any other condition except for DME that could affect interpretation of study assessments
Other
- Be pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Sunshine Eye Surgeons Coordinator of this site? Confirm its status | Albans | Australia | Recruiting |
| Eye Surgery Associates Pty Ltd Coordinator of this site? Confirm its status | Malvern | Australia | Recruiting |
| Marsden Eye Specialists Coordinator of this site? Confirm its status | Parramatta | Australia | Recruiting |
| South Eastern Sydney Local Health District Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Sydney West Retina Coordinator of this site? Confirm its status | Westmead | Australia | Terminated |
| Princess Alexandria Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Terminated |
| Davinci Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| LLC Caucasus Medical Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Ltd Akhali Mzera Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.