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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06701721

Enrollment

Registered

2024-11-22

Start date

2024-12-20

Completion date

2027-05-31

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Diabetic Retinopathy

Keywords

Diabetic Macular Oedema, Non-proliferative Diabetic Retinopathy

Brief summary

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.

Interventions

DRUGTHN391

THN391, IVT injection, 3\*Q4W (every 4 weeks)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multiple Ascending Dose

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Contacts

CONTACTLiza Wallace

lwallace@therinibio.com+1 (925) 819-1952

CONTACTJoel Naor

jnaor@therinibio.com+1 (510) 364-2776

STUDY_DIRECTORJoel Naor

Therini Bio, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026