Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)

NCT05414747 | Suspended

• 1 other identifier: ABV-1701-02
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

Brief Summary

A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (6)

• Change in best-corrected visual acuity (BCVA)

  180 days

• Number of surgeries

  90 days

• Secondary surgical/medical interventions - IOP elevation

  180 days

• Secondary surgical/medical interventions - cataract formation

  180 days

• Secondary surgical/medical interventions - corneal abnormalities

  180 days

Study Arms (2)

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

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

Device: SF6 Gas

Interventions

ABV-1701 DEVICE

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

Participants randomized to ABV-1701 Ocular Endotamponade

SF6 Gas DEVICE

SF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV)

Participants randomized to SF6 Gas Ocular Endotamponade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• BioFirst Corporation: lead
• ABVC BioPharma, Inc: collaborator

Study Sites (4)

Sydney Eye Hospital

Sydney, New South Wales, 2155, Australia

Location

East Melbourne Eye Group

Melbourne, Victoria, Australia

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Srinagarind Hospital

Khon Kaen, Thailand

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Richard CH King, Ph.D.

  ABVC BioPharma, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ABV-1701 Ocular Endotamponade

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: April 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); TH (2)