A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THN391.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema, Diabetic Retinopathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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
- Drug THN391
THN391, IVT injection, 3\*Q4W (every 4 weeks)
Primary outcome measures
- Adverse Events [Time frame: Up to 16 weeks following first dose administration]
Secondary outcome measures (2)
- Change in Visual Acuity [Time frame: Up to 16 weeks following first dose administration]
- Change in Retinal Edema [Time frame: Up to 16 weeks following first dose administration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 7 centers
- Marsden Eye Specialists — Parramatta
- South Eastern Sydney Local Health District — Sydney
- Sydney West Retina — Westmead
- Princess Alexandria Hospital — Woolloongabba
- Royal Adelaide Hospital — Adelaide
- Sunshine Eye Surgeons — Albans
- Eye Surgery Associates Pty Ltd — Malvern
Identifiers
NCT: NCT06701721 · THN391-OPT-101