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

Phase 1RecruitingNCT06701721

Therini Bio Pty Ltd21 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema Diabetic Retinopathy

Interventions

THN391 MADDRUG

Route of administration- IVT injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Marsden Eye Specialists

Parramatta, New South Wales, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Adverse Events

Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities

Time frame: Up to 16 weeks following first dose administration

Secondary Outcomes

Change in Visual Acuity

Measured using ETDRS method

Time frame: Up to 16 weeks following first dose administration

Change in Retinal Edema

Measured with Optical Coherence Tomography (OCT)

Time frame: Up to 16 weeks following first dose administration

Central Contacts

Liza Wallace

CONTACT

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

Joel Naor

CONTACT

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

Data from ClinicalTrials.gov

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