A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06701721
Intervention or treatment
DRUG: THN391 MAD
Conditions
- Diabetic Macular Edema
- Diabetic Retinopathy
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Research sites nearby
Closest Location:
Marsden Eye Specialists
Select from list below to view details:
Marsden Eye Specialists
Parramatta, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
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Who is running the clinical trial?
Therini Bio Pty Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cohort 1
| Drug: THN391 |
EXPERIMENTAL: Cohort 2
| Drug: THN391 |
EXPERIMENTAL: Cohort 3
| Drug: THN391 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities | Up to 16 weeks following first dose administration |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity | Measured using ETDRS method | Up to 16 weeks following first dose administration |
| Change in Retinal Edema | Measured with Optical Coherence Tomography (OCT) | Up to 16 weeks following first dose administration |
References
Clinical Trials Gov: A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.Other trials to consider
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