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

Therini Bio Pty Ltd

Status and phase: Not yet enrolling; Phase 1

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Drug: THN391 MAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT06701721

THN391-OPT-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Sequential Multiple Ascending Doses

Experimental group

Description:

Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.

Treatment:

Drug: THN391 MAD