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Trial details imported from ClinicalTrials.gov
Ethics application status
A Phase I Study of Vitargus® in Vitrectomy
A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Devices - Vitargus, BFC-1401
Experimental: Active arm - Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute
Treatment: Devices: Vitargus, BFC-1401
A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
Intervention code 
Comparator / control treatment
Primary outcome 
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.
Secondary outcome 
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.
Key inclusion criteria
1. Male or female adults, aged 18 years or older at screening.
2. 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
3. BCVA of 20/40 to 20/2000.
4. Scheduled vitrectomy with vitreous substitute.
5. Must be able and willing to provide written informed consent, attend all scheduled
visits and comply with all study procedures.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
A participant meeting any of the following criteria was to be excluded from the study:
1. Any active intraocular or periocular infection or inflammation.
2. Only one functional eye.
3. Ocular disorders in the study eye that may confound the interpretation of the study
results; macular oedema not requiring vitrectomy surgery, choroidal
4. High refractive error demonstrating >6 diopters of myopia.
5. Any ophthalmic condition that reduces the clarity of the optical media that interferes
with ophthalmic examination and adequate imaging (advanced cataract or corneal
6. Uncontrolled glaucoma defined as intraocular pressure > 30 mmHg on maximal therapy.
7. Aphakia or absence of the posterior capsule.
8. Known hypersensitivity to hyaluronic acid or ADH.
9. Uncontrolled blood pressure defined as systolic value = 160 mmHg or diastolic value
=100 mmHg at screening.
10. Uncontrolled diabetes defined as glycated haemoglobin (HbA1c) > 12%.
11. Stroke or myocardial infarction within 90 days of baseline.
12. Severe generalised disease resulting in a life expectancy shorter than 1 year.
13. Currently pregnant or breastfeeding.
14. 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:
- Total abstinence (when this is in line with the preferred and usual lifestyle of
the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal,
post-ovulation methods) was not acceptable.
- Female sterilisation (surgical bilateral oopthorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment.
In case of oophorectomy alone, this was acceptable only when the reproductive
status of the woman was confirmed by follow-up hormone level assessment.
- Male sterilisation (at least 6 months prior to screening). For female
participants on the study, the vasectomised male partner was to be the sole
partner for that participant.
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
- Use of oral, injected or implanted hormonal methods of contraception or other
forms of hormonal contraception that have comparable efficacy (failure rate<1%),
for example hormone vaginal ring or transdermal hormone contraception.
- Placement of an intrauterine device or intrauterine system.
- In the case of use of oral contraception, women were to be stable on the same
pill for a minimum of 3 months before taking study treatment.
- The use of an effective contraception method was to continue for 4 months
post-vitrectomy and injection of the investigational product, in line with the
follow-up period of the study.
- Because the experimental investigational product in this study may affect an
unborn baby, males participating in this study were not to father a baby while on
the study, and for 4 months following the injection of study medication.
- Women were considered post-menopausal and not of child-bearing potential if they
had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
profile (e.g. age appropriate, history of vasomotor symptoms) or had surgical
bilateral oophorectomy (with or without hysterectomy) or tubal ligation, at least
six weeks prior to the study. In the case of oophorectomy alone, only when the
reproductive status of the woman was confirmed by follow-up hormone level
assessment was she considered to be not of child-bearing potential.
15. Participation in any study involving an investigational drug or device within the past
30 days or ongoing participation in a study with an investigational drug or device.
16. Any clinical evidence that the Investigator felt would place the participant at
increased risk with the investigational product.
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Trial related presentations / publications
Andrew Chang, MD, Ph.D
Sydney Retina Clinic | Medical Director