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

T

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)

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

Trial contacts and locations

2

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Central trial contact

Liza Wallace; Joel Naor

Data sourced from clinicaltrials.gov

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