Vitreo-retinal SurgeryNCT04481386
A Phase I Study of Vitargus® in Vitrectomy
A study testing Vitargus, BFC-1401 in people with Vitreo-retinal Surgery, run by BioFirst Corporation at 1 site in Australia.
Trial summary
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreo-retinal Surgery
- What is being tested?
- Vitargus, BFC-1401
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2017to 2 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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:
- 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.
- 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.
- Any clinical evidence that the Investigator felt would place the participant at increased risk with the investigational product.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000
About this study
Official title: A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Read the detailed description
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.
- Conditions
- Vitreo-retinal Surgery
- Being tested
- Vitargus, BFC-1401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitargus, BFC-1401Device
A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute Receives: Device: Vitargus, BFC-1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (1)
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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Feb 2017
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreo-retinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFirst Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Chang, MD, Ph.D, Principal investigator, Sydney Retina Clinic | Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481386
- Sponsor's protocol ID
- BFC-1401
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery
- ClinicalTrials.gov ID
- NCT04481386
- Acronym / sponsor ID
- BFC-1401
- Conditions
- Vitreo-retinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- BioFirst CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Device: Vitargus, BFC-1401Participants with a diagnosis of retinal detachment or vitreous haemorrhage, who are scheduled for vitrectomy surgery with a vitreous substitute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitargus, BFC-1401A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery. | Device | Active arm |
Primary outcome
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.
1 secondary outcome
Efficacy for best corrected visual acuity (BCVA); retinal attachment and hydrogel degradation
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Chang, MD, Ph.D principal investigator
Sydney Retina Clinic | Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitargus, BFC-1401 in people with Vitreo-retinal Surgery, run by BioFirst Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/tolerability: Incidence of Treatment-Emergent Adverse Events (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.