A Phase I Study of Vitargus® in Vitrectomy

NCT04481386 | Completed DMC

• 1 other identifier: BFC-1401
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery

Conditions

Vitreo-retinal Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  120 days

Secondary Outcomes (1)

• Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation

  120 days

Study Arms (1)

Active arm

EXPERIMENTAL

Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute

Device: Vitargus, BFC-1401

Interventions

Vitargus, BFC-1401 DEVICE

A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.

Active arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults, aged 18 years or older at screening.
• a) Diagnosis of Diagnosis of Diagnosis of Diagnosis of complex or rhegmatogenous retinal detachment, or chronic retinal detachment with failure of gas or silicone oil treatment, OR b) Diagnosis of any vitreous haemorrhage that requires vitrectomy surgery
• BCVA of 20/40 to 20/2000.
• Scheduled vitrectomy with vitreous substitute.
• Must be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures.

You may not qualify if:

• A participant meeting any of the following criteria was to be excluded from the study:
• Any active intraocular or periocular infection or inflammation.
• Only one functional eye.
• Ocular disorders in the study eye that may confound the interpretation of the study results; macular oedema not requiring vitrectomy surgery, choroidal neovascularisation.
• High refractive error demonstrating \>6 diopters of myopia.
• Any ophthalmic condition that reduces the clarity of the optical media that interferes with ophthalmic examination and adequate imaging (advanced cataract or corneal opacities).
• Uncontrolled glaucoma defined as intraocular pressure \> 30 mmHg on maximal therapy.
• Aphakia or absence of the posterior capsule.
• Known hypersensitivity to hyaluronic acid or ADH.
• Uncontrolled blood pressure defined as systolic value ≥ 160 mmHg or diastolic value ≥100 mmHg at screening.
• Uncontrolled diabetes defined as glycated haemoglobin (HbA1c) \> 12%.
• Stroke or myocardial infarction within 90 days of baseline.
• Severe generalised disease resulting in a life expectancy shorter than 1 year.
• Currently pregnant or breastfeeding.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods included:

Sponsors & Collaborators

• BioFirst Corporation: lead

Study Sites (1)

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Related Links

• Related Info

Study Officials

• Andrew Chang, MD, Ph.D

  Sydney Retina Clinic | Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 22, 2020
• Study Start: February 1, 2017
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: September 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)