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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04481386




Registration number
NCT04481386
Ethics application status
Date submitted
15/07/2020
Date registered
22/07/2020
Date last updated
9/09/2020

Titles & IDs
Public title
A Phase I Study of Vitargus® in Vitrectomy
Scientific title
A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery
Secondary ID [1] 0 0
BFC-1401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitreo-retinal Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
120 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
120 days

Eligibility
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
surgery

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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
neovascularisation.

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
opacities).

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
cervical/vault caps).

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioFirst Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Trial website
https://clinicaltrials.gov/show/NCT04481386
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Chang, MD, Ph.D
Address 0 0
Sydney Retina Clinic | Medical Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications