Actively Recruiting
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
Led by Therini Bio Pty Ltd · Updated on 2024-12-19
21
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of THN391 given as a monotherapy for patients with diabetic macular edema (DME) secondary to non-proliferative diabetic retinopathy. This Phase 1b open-label study aims to assess how well patients tolerate escalating doses of THN391 and observe its biological activity in the eye. Participants will be enrolled sequentially into three groups to receive low, medium, and high doses of THN391 via intravitreal injection. Each participant will receive three monthly treatments during this multiple ascending dose study. The focus is on monitoring safety and tolerability across these escalating doses. Throughout the study, participants will be monitored for adverse events up to 16 weeks after the first dose. Researchers will also evaluate changes in visual acuity and retinal swelling to understand the drug's biological effects. The total study participation includes treatment and follow-up to assess safety and preliminary efficacy over this time frame.
CONDITIONS
Brief Title
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive three monthly intravitreal injections of THN391 at escalating doses.
3 monthly visits (in-person) for dosing
Duration - Up to 13 weeks after the last treatment
Participants are monitored for safety and biological response following the last dose of THN391.
Visits as scheduled for up to 16 weeks following first dose
Trial Site Locations
Total: 2 locations
1
Marsden Eye Specialists
Parramatta, New South Wales, Australia, 2150
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
Research Team
L
Liza Wallace
J
Joel Naor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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