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
Qualifiers
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
Treatments tested in this trial
- THN391
Treatment groups
21 Participants
are divided into 3 treatment groupsSponsors and collaborators
Therini Bio Pty Ltd
Lead sponsor
Therini Bio, Inc.
Collaborator
Source ClinicalTrials.gov