Diabetic Macular EdemaPhase 1NCT06701721
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
A Phase 1 study testing THN391 in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Therini Bio Pty Ltd at 10 sites in 2 countries.
Trial summary
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy
- What is being tested?
- THN391
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 Dec 2024to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Australia7 sites, 5 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Jagjit S Gilhotra, Prof, +61 08 7074 2257, Jagjit.Gilhotra@sa.gov.au
Jagjit Gilhotra
- Recruiting
Sunshine Eye Surgeons
Albans, Victoria, 3021
Hien Nguyen, +61 3 9077 3235, thanh.nguyen@unimelb.edu.au
Hien Nguyen
- Recruiting
Eye Surgery Associates Pty Ltd
Malvern, Victoria, 3144
Andrew Symons, +61 402 133 315, andrewsymons@gmail.com
Andrew Symons
- Recruiting
Marsden Eye Specialists
Parramatta, New South Wales, 2150
Jennifer Arnold, Dr, + 61 2 9635 7077, jennifer.arnold@marsdeneye.com
Jennifer Arnold
- Recruiting
South Eastern Sydney Local Health District
Sydney, New South Wales, 2000
Samatha Fraser-Bell, +61 02 9382 7309, therini.mrg.coordinator@groups.sydney.edu.au
Samatha Fraser-Bell
- Terminated
Sydney West Retina
Westmead, New South Wales, 2145
- Terminated
Princess Alexandria Hospital
Woolloongabba, Queensland, 4102
Georgia3 sites, 3 recruiting
- Recruiting
Ltd Akhali Mzera
Tbilisi, 0179
Shalva Skhirtladze, +995 599 80 76 80, shalva_skhirtladze@yahoo.com
Shalva Skhirtladze
- Recruiting
LLC Caucasus Medical Center
Tbilisi, 0186
Mikheil Omiadze, +995599564711, omiadzem@yahoo.com
Mikheil Omiadze
- Recruiting
Davinci
Tbilisi, 0194
Nikoloz Labauri, +995 599 00 37 44, nlabauri@yahoo.com
Nikoloz Labauri
About this study
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.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Read the detailed description
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.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Being tested
- THN391
- Keywords
- Diabetic Macular Oedema, Non-proliferative Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THN391Drug
THN391, IVT injection, 3*Q4W (every 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | THN 391 (low dosage), IVT injection Receives: Drug: THN391 |
| Cohort 2 | Experimental | THN 391 (medium dosage), IVT injection Receives: Drug: THN391 |
| Cohort 3 | Experimental | THN 391 (high dosage), IVT injection Receives: Drug: THN391 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Measured: Up to 16 weeks following first dose administration
Secondary outcomes (2)
Change in Visual Acuity
Measured using ETDRS method
Measured: Up to 16 weeks following first dose administration
Change in Retinal Edema
Measured with Optical Coherence Tomography (OCT)
Measured: Up to 16 weeks following first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Dec 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multiple Ascending Dose
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therini Bio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therini Bio, Inc.
- Responsible party
- Sponsor
- Investigators
- Joel Naor, Study director, Therini Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701721
- Sponsor's protocol ID
- THN391-OPT-101
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06701721
- Acronym / sponsor ID
- THN391-OPT-101
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy
- Keywords
- Diabetic Macular Oedema, Non-proliferative Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Therini Bio Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Therini Bio, Inc.
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multiple Ascending Dose
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: THN391THN 391 (low dosage), IVT injection |
| Cohort 2 | Experimental | Drug: THN391THN 391 (medium dosage), IVT injection |
| Cohort 3 | Experimental | Drug: THN391THN 391 (high dosage), IVT injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THN391THN391, IVT injection, 3*Q4W (every 4 weeks) | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Adverse Events
Time frame: Up to 16 weeks following first dose administration
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
2 secondary outcomes
Change in Visual Acuity
Time frame: Up to 16 weeks following first dose administration
Change in Retinal Edema
Time frame: Up to 16 weeks following first dose administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Naor study director
Therini Bio, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing THN391 in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Therini Bio Pty Ltd at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liza Wallace (+1 (925) 819-1952, lwallace@therinibio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Up to 16 weeks following first dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.