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

PHASE1NOT_YET_RECRUITING

THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-11-25

Primary completion: 2025-10-31

Study completion finish: 2026-02-28

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06701721

Intervention or treatment

DRUG: THN391 MAD

Conditions

• Diabetic Retinopathy
• Diabetic Macular Edema

Condition: Diabetic Retinopathy, Diabetic Macular Edema
DRUG: THN391 MAD
Adelaide, South Australia, Australia and more
Sponsor: Therini Bio Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Marsden Eye Specialists
Parramatta, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Sequential Multiple Ascending Doses Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.	DRUG: THN391 MAD Route of administration- IVT injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Adverse Events	Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities	Up to 16 weeks following first dose administration

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in Visual Acuity	Measured using ETDRS method	Up to 16 weeks following first dose administration
Change in Retinal Edema	Measured with Optical Coherence Tomography (OCT)	Up to 16 weeks following first dose administration

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.