A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTherini Bio Pty Ltd
About this trial
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Sequential
Treatments tested in this trial
THN391
DrugTHN391, IVT injection, 3\*Q4W (every 4 weeks)
Treatment groups
21 Participants
are divided into 3 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Time frame
Up to 16 weeks following first dose administrationSecondary outcomes
1
Change in Visual Acuity
Measured using ETDRS method
Time frame
Up to 16 weeks following first dose administration2
Change in Retinal Edema
Measured with Optical Coherence Tomography (OCT)
Time frame
Up to 16 weeks following first dose administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Therini Bio Pty Ltd
Lead sponsor
Therini Bio, Inc.
Collaborator
Source ClinicalTrials.gov