Retinal DetachmentNCT05414747
Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
A study testing ABV-1701 and SF6 Gas in people with Retinal Detachment, run by BioFirst Corporation at 4 sites in 2 countries.
Trial summary
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- ABV-1701 and SF6 Gas
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Apr 2023to 15 Dec 2025
- 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 on the day of screening;
- Uncomplicated retinal detachment defined as one of the following:
- The first instance of a small macular hole (<400 microns)
- 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
- 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
- Any active intraocular or periocular infection or inflammation;
- Vitreous haemorrhage
- Complicated Retinal detachments due to the following:
- Detachment due to Trauma
- Detachment due to Uveitis
- Chronic detachments defined as 2 or more surgeries
Show all 26Show fewer
- PVR grade CA
- Only one functional eye;
- 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;
- High refractive error demonstrating >6 diopters of myopia;
- An ophthalmic condition that reduces the clarity of the ocular media that may interfere with ophthalmic examination or imaging. i.e. Cataract, corneal opacity;
- Uncontrolled glaucoma defined as intraocular pressure >30 mmHg on maximal therapy;
- Aphakia or the absence of the posterior capsule;
- Known hypersensitivity to hyaluronic acid or acid dihydrazide (ADH);
- Uncontrolled blood pressure defined as systolic value >160 mmHg or diastolic value > 100 mmHg at screening;
- Uncontrolled diabetes defined as glycated hemoglobin (HbA1c) >12%;
- Pregnant or breastfeeding at the time of screening;
- 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).
- 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 feels would place the participant at increased risk with the investigational product.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia2 sites
East Melbourne Eye Group
Melbourne, Victoria
Sydney Eye Hospital
Sydney, New South Wales, 2155
About this study
Official title: A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Read the detailed description
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE) The objective of the investigation is to document the safety and effectiveness of the ABV-1701 OE when compared to the SF6 Gas OE.
- Conditions
- Retinal Detachment
- Being tested
- ABV-1701, SF6 Gas
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABV-1701Device
ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH)
SF6 GasDevice
SF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV)
| Study group | Role | What they receive |
|---|---|---|
| Participants randomized to ABV-1701 Ocular Endotamponade | Experimental | Participants randomized to the interventional device ABV-1701 Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment Receives: Device: ABV-1701 |
| Participants randomized to SF6 Gas Ocular Endotamponade | Active comparator | Participants randomized to the control device SF6 Gas Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment Receives: Device: SF6 Gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anatomical retinal attachment success
Rate of anatomical retinal attachment success (percent) at Day 90 from an uncomplicated retinal detachment at baseline. Successful cases measured by the absence of any adverse event or complication at Day 90.
Measured: 90 days
Secondary outcomes (6)
Change in best-corrected visual acuity (BCVA)
Change in best-corrected visual acuity (BCVA) from baseline
Measured: 180 days
Number of surgeries
Number of surgeries (required to reattach the retina if recurrent retinal detachment occurs) between Day 0 and Day 90
Measured: 90 days
Secondary surgical/medical interventions - IOP elevation
Number of secondary surgical/medical interventions due to IOP elevation
Measured: 180 days
Secondary surgical/medical interventions - cataract formation
Number of secondary surgical/medical interventions due to cataract formation
Measured: 180 days
Secondary surgical/medical interventions - corneal abnormalities
Number of secondary surgical/medical interventions due to corneal abnormalities
Measured: 180 days
Secondary surgical/medical interventions - adverse events
Number of secondary surgical/medical interventions due to adverse events (AE)s
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start15 Apr 2023
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2025 (estimated)
Why it stopped: waiting the new batch of investigational product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- ABV-1701 Ocular Endotamponade
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioFirst Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ABVC BioPharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard CH King, Ph.D., Study director, ABVC BioPharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414747
- Sponsor's protocol ID
- ABV-1701-02
- Status last verified
- Nov 2023
- First submitted
- 7 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
- ClinicalTrials.gov ID
- NCT05414747
- Acronym / sponsor ID
- ABV-1701-02
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: waiting the new batch of investigational product.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BioFirst CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ABVC BioPharma, Inc.
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 10 Jun 2022 (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 Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Detailed description
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE) The objective of the investigation is to document the safety and effectiveness of the ABV-1701 OE when compared to the SF6 Gas OE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ABV-1701 Ocular Endotamponade
| Arm | Type | Receives |
|---|---|---|
| Participants randomized to ABV-1701 Ocular Endotamponade | Experimental | Device: ABV-1701Participants randomized to the interventional device ABV-1701 Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment |
| Participants randomized to SF6 Gas Ocular Endotamponade | Active comparator | Device: SF6 GasParticipants randomized to the control device SF6 Gas Ocular Endotamponade undergoing the vitrectomy surgery for uncomplicated retinal detachment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adults aged 18 years or older on the day of screening;
- Uncomplicated retinal detachment defined as one of the following:
- 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 (26 listed)
- Any active intraocular or periocular infection or inflammation;
- Vitreous haemorrhage
- Complicated Retinal detachments due to the following:
- Only one functional eye;
- 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;
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 |
|---|---|---|
| ABV-1701ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH) | Device | Participants randomized to ABV-1701 Ocular Endotamponade |
| SF6 GasSF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV) | Device | Participants randomized to SF6 Gas Ocular Endotamponade |
Primary outcome
Rate of anatomical retinal attachment success
Time frame: 90 days
Rate of anatomical retinal attachment success (percent) at Day 90 from an uncomplicated retinal detachment at baseline. Successful cases measured by the absence of any adverse event or complication at Day 90.
6 secondary outcomes
Change in best-corrected visual acuity (BCVA)
Time frame: 180 days
Number of surgeries
Time frame: 90 days
Secondary surgical/medical interventions - IOP elevation
Time frame: 180 days
Secondary surgical/medical interventions - cataract formation
Time frame: 180 days
Secondary surgical/medical interventions - corneal abnormalities
Time frame: 180 days
Secondary surgical/medical interventions - adverse events
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Richard CH King, Ph.D. study director
ABVC BioPharma, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABV-1701 and SF6 Gas in people with Retinal Detachment, run by BioFirst Corporation at 4 sites in 2 countries.
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 6 inclusion and 26 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: paused, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Thailand. 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?
Results are not available in the source record.
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?
Rate of anatomical retinal attachment success (time frame: 90 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 18 Nov 2023.