A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Study Objectives: Primary Objective • To evaluate the safety/tolerability of a single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery. Secondary Objective * To assess retinal attachment and hydrogel degradation at Day 120. * To assess best corrected visual acuity (BCVA) after vitrectomy surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Safety/tolerability: Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events. Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA), and data summarised by System Organ Class and preferred term.
Time frame: 120 days
Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation
To assess best corrected visual acuity (BCVA) by LogMAR change from baseline over time after vitrectomy surgery. To assess retinal attachment and hydrogel degradation by slit lamp biomicroscopy exam findings, dilated ophthalmoscopy exam findings, colour fundus photography, and OCT findings over time after vitrectomy surgery.
Time frame: 120 days
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