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New eye injection aims to tackle Diabetes-Related vision loss

NCT ID NCT06701721

Disease control Sponsor: Therini Bio Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests an experimental drug called THN391, given as an injection into the eye, for people with diabetic macular edema (DME) — a condition where fluid builds up in the retina due to diabetes, causing vision loss. The trial involves 21 adults aged 18 to 80 with DME and vision loss. Researchers will check for side effects and measure changes in vision and retinal swelling over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
THN391
What this could lead to
If successful, THN391 could offer a new treatment option for diabetic macular edema, potentially improving vision and reducing retinal swelling.
What could go wrong
This is an early-phase trial with only 21 participants, so results may not apply broadly. The drug may cause side effects or fail to improve vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema diabetic retinopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema Diabetic retinopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eye Surgery Associates Pty Ltd

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Marsden Eye Specialists

    RECRUITING

    Parramatta, New South Wales, 2150, Australia

  • Princess Alexandria Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • South Eastern Sydney Local Health District

    RECRUITING

    Sydney, New South Wales, 2000, Australia

  • Sunshine Eye Surgeons

    RECRUITING

    Albans, Victoria, 3021, Australia

  • Sydney West Retina

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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