Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of Vitargus® in Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04481386
Recruitment Status : Completed
First Posted : July 22, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
BioFirst Corporation

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

Condition or disease Intervention/treatment Phase
Vitreo-retinal Surgery Device: Vitargus, BFC-1401 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Australia, New South Wales
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
BioFirst Corporation
Investigators
Layout table for investigator information
Principal Investigator: Andrew Chang, MD, Ph.D Sydney Retina Clinic | Medical Director
Additional Information:
Layout table for additonal information
Responsible Party: BioFirst Corporation
ClinicalTrials.gov Identifier: NCT04481386    
Other Study ID Numbers: BFC-1401
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No