A Phase I Study of Vitargus® in Vitrectomy
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|ClinicalTrials.gov Identifier: NCT04481386|
Recruitment Status : Completed
First Posted : July 22, 2020
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vitreo-retinal Surgery||Device: Vitargus, BFC-1401||Not Applicable|
• To evaluate the safety/tolerability of a single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
- To assess retinal attachment and hydrogel degradation at Day 120.
- To assess best corrected visual acuity (BCVA) after vitrectomy surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||July 2, 2018|
|Actual Study Completion Date :||July 2, 2018|
Experimental: Active arm
Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute
Device: Vitargus, BFC-1401
A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
- Safety/tolerability: Incidence of Treatment-Emergent Adverse Events [ Time Frame: 120 days ]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.
- Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation [ Time Frame: 120 days ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481386
|Australia, New South Wales|
|Sydney Retina Clinic and Day Surgery|
|Sydney, New South Wales, Australia, 2000|
|Principal Investigator:||Andrew Chang, MD, Ph.D||Sydney Retina Clinic | Medical Director|