What is THN391 studying for diabetic macular edema?

THN391 is being studied to evaluate its safety and early effects in treating diabetic macular edema related to diabetic retinopathy. Researchers aim to understand how different doses impact vision and retinal swelling. The study is sponsored by Therini Bio Pty Ltd and focuses on gathering initial information about this treatment.

Who may be eligible for this diabetic macular edema clinical trial?

Adults aged 18 to 80 with a diagnosis of diabetic macular edema and vision loss in the affected eye may be eligible. People who have had recent eye surgery or are pregnant or breastfeeding are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic macular edema clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 80Years

All Genders

ID06701721

Phase 1b Open-Label Study Evaluating Safety and Effects of Intravitreal THN391 for Diabetic Macular Edema in Diabetic Retinopathy

Led by Therini Bio Pty Ltd · Updated on 2026-07-02

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of THN391 in people with diabetic macular edema DME related to non-proliferative diabetic retinopathy. This Phase 1b study focuses on how different doses of THN391 affect vision and retinal swelling in this eye condition. Participants will be enrolled into three groups receiving escalating doses of THN391 through intravitreal IVT injections. Each participant will receive three monthly injections of THN391 at low, medium, or high doses. The study is open-label and sequential, meaning all participants and researchers know the treatment given, and dosing increases with each group. During the study, participants will be monitored for adverse events for up to 16 weeks after their first injection. Researchers will also measure changes in visual acuity and retinal edema to assess treatment effects. Participation involves multiple visits for injections and assessments over approximately 4 months.

CONDITIONS

Brief Title

A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
Be between 18 and 80 years old at the time of consent
Have a diagnosis of diabetic macular edema
Have vision loss in the study eye

You will not qualify if you...

Be pregnant or breastfeeding
Have had cataract surgery or any other ocular surgery in the study eye within 3 months before screening
Have any other condition except for diabetic macular edema that could affect interpretation of study assessments

Research Team

Liza Wallace

Joel Naor

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