Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ABV-1701
Treatment: Devices - SF6 Gas

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: ABV-1701
ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH)

Treatment: Devices: SF6 Gas
SF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of anatomical retinal attachment success
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Change in best-corrected visual acuity (BCVA)
Timepoint [1] 0 0
180 days
Secondary outcome [2] 0 0
Number of surgeries
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
Secondary surgical/medical interventions - IOP elevation
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Secondary surgical/medical interventions - cataract formation
Timepoint [4] 0 0
180 days
Secondary outcome [5] 0 0
Secondary surgical/medical interventions - corneal abnormalities
Timepoint [5] 0 0
180 days
Secondary outcome [6] 0 0
Secondary surgical/medical interventions - adverse events
Timepoint [6] 0 0
180 days

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)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Syd
Recruitment hospital [2] 0 0
East Melbourne Eye Group - Melbourne
Recruitment postcode(s) [1] 0 0
2155 - Syd
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Thailand
State/province [1] 0 0
Bangkok
Country [2] 0 0
Thailand
State/province [2] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioFirst Corporation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ABVC BioPharma, Inc
Address [1] 0 0
Country [1] 0 0

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/ct2/show/NCT05414747
Trial related presentations / publications
Public notes

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/ct2/show/NCT05414747