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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05414747




Registration number
NCT05414747
Ethics application status
Date submitted
7/06/2022
Date registered
10/06/2022
Date last updated
18/11/2023

Titles & IDs
Public title
Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Scientific title
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Secondary ID [1] 0 0
ABV-1701-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal Detachment 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surgical implantation of the PCL Breast scaffold with autologous fat grafting
Treatment: Devices - ABV-1701

Experimental: Participants randomized to ABV-1701 Ocular Endotamponade - Participants randomized to the interventional device ABV-1701 Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment

Active comparator: Participants randomized to SF6 Gas Ocular Endotamponade - Participants randomized to the control device SF6 Gas Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment


Treatment: Devices: Surgical implantation of the PCL Breast scaffold with autologous fat grafting
Single shot of prophylactic perioperative antibiotics is given to the patient. A suitable incision is made to provide access followed by mobilisation of the breast gland.If present, the silicone implant is removed and capsulectomy performed. The implant pocket shall be rinsed with saline or antiseptic and a surgical drain shall be placed in the pocket at the discretion of the PI. The PCL Breast scaffold shall be inserted into the pocket and fixed using 2 to 4 sutures. The incision is closed. Liposuction is performed from another area of the body and lipofilling is performed within the breast scaffold. Sterile bandaging is applied and a daily wound revision is performed whilst an inpatient. A prophylactic antibiotic shall be administered to the patient.The patients shall be hospitalized overnight for clinical observation.

Treatment: Devices: ABV-1701
ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Male or female adults aged 18 years or older on the day of screening;
2. Uncomplicated retinal detachment defined as one of the following:

1. The first instance of a small macular hole (<400 microns)
2. The first instance of a single small (<400 microns) primary tear extending less than 2 clock hours. There is no limit on the number or the position of the break(s). The tear can be PVR grade A (Vitreous haze and pigment clumps) or B (Surface retinal wrinkling, rolled edges of the retinal, retinal stiffness, and vessel tortuosity), but not more than grade B
3. Scheduled vitrectomy with vitreous substitute;
4. 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any active intraocular or periocular infection or inflammation;
2. Vitreous haemorrhage
3. Complicated Retinal detachments due to the following:

1. Detachment due to Trauma
2. Detachment due to Uveitis
3. Chronic detachments defined as 2 or more surgeries
4. PVR grade CA
4. Only one functional eye;
5. Ocular disorders in the study eye that could confound the interpretation of the study results. i.e. macular edema not requiring vitrectomy surgery, choroidal neovascularization;
6. High refractive error demonstrating >6 diopters of myopia;
7. An ophthalmic condition that reduces the clarity of the ocular media that may interfere with ophthalmic examination or imaging. i.e. Cataract, corneal opacity;
8. Uncontrolled glaucoma defined as intraocular pressure >30 mmHg on maximal therapy;
9. Aphakia or the absence of the posterior capsule;
10. Known hypersensitivity to hyaluronic acid or acid dihydrazide (ADH);
11. Uncontrolled blood pressure defined as systolic value >160 mmHg or diastolic value > 100 mmHg at screening;
12. Uncontrolled diabetes defined as glycated hemoglobin (HbA1c) >12%;
13. Pregnant or breastfeeding at the time of screening;
14. Women of childbearing potential, defined as women physiologically capable of becoming pregnant unless using effective methods of contraception during the study period. The effective contraception methods include:

* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) is not acceptable.
* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should 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 (IUD) or intrauterine system (IUS).
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 feels would place the participant at increased risk with the investigational product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status

Summary
Brief summary
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Trial website
https://clinicaltrials.gov/study/NCT05414747
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Richard CH King, Ph.D.
Address 0 0
ABVC BioPharma, Inc
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05414747