THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
THN391, IVT injection, 3\*Q4W (every 4 weeks)
Marsden Eye Specialists
Parramatta, New South Wales, Australia
RECRUITINGSouth Eastern Sydney Local Health District
Sydney, New South Wales, Australia
RECRUITINGAdverse Events
Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities
Time frame: Up to 16 weeks following first dose administration
Change in Visual Acuity
Measured using ETDRS method
Time frame: Up to 16 weeks following first dose administration
Change in Retinal Edema
Measured with Optical Coherence Tomography (OCT)
Time frame: Up to 16 weeks following first dose administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sydney West Retina
Westmead, New South Wales, Australia
Princess Alexandria Hospital
Woolloongabba, Queensland, Australia
TERMINATEDRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGSunshine Eye Surgeons
Albans, Victoria, Australia
RECRUITINGEye Surgery Associates Pty Ltd
Malvern, Victoria, Australia
RECRUITINGLtd Akhali Mzera
Tbilisi, Georgia
RECRUITINGLLC Caucasus Medical Center
Tbilisi, Georgia
RECRUITINGDavinci
Tbilisi, Georgia
RECRUITING