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)

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

Study Overview

• Status: Suspended
• Conditions: Retinal Detachment
• Intervention / Treatment: Device: ABV-1701; Device: SF6 Gas

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Syd, New South Wales, Australia, 2155
      • Sydney Eye Hospital
      • Contact: Maria Williams; Email: maria.williams@sydney.edu.au
      • Principal Investigator: Matthew Simunovic
  • Victoria
    • Melbourne, Victoria, Australia
      • East Melbourne Eye Group
      • Contact: Carissa El Khoury; Phone Number: +61394171011; Email: orthoptic@emeg.com.au
      • Principal Investigator: Elvis Ojaimi
• Thailand
  • Bangkok, Thailand
    • Ramathibodi Hospital
    • Contact: Wannee Onrahong; Phone Number: +66869926781; Email: wannee.orn@mahidol.ac.th
    • Contact: Patthama Ditthachot; Phone Number: +66859210828; Email: oh28@hotmail.com
    • Principal Investigator: Duangnate Rojanaporn
  • Khon Kaen, Thailand
    • Srinagarind Hospital
    • Contact: Suphad Kaewphanna; Phone Number: +66872261319; Email: suphka@kku.ac.th
    • Contact: Nattapon Seekangpai; Phone Number: +66858299199; Email: nattapolseekangpai@gmail.com
    • Principal Investigator: Thuss Sanguansak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: ABV-1701; ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH)
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	Device: SF6 Gas; SF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in best-corrected visual acuity (BCVA)	Change in best-corrected visual acuity (BCVA) from baseline	180 days
Number of surgeries	Number of surgeries (required to reattach the retina if recurrent retinal detachment occurs) between Day 0 and Day 90	90 days
Secondary surgical/medical interventions - IOP elevation	Number of secondary surgical/medical interventions due to IOP elevation	180 days
Secondary surgical/medical interventions - cataract formation	Number of secondary surgical/medical interventions due to cataract formation	180 days
Secondary surgical/medical interventions - corneal abnormalities	Number of secondary surgical/medical interventions due to corneal abnormalities	180 days
Secondary surgical/medical interventions - adverse events	Number of secondary surgical/medical interventions due to adverse events (AE)s	180 days

Collaborators and Investigators

• Sponsor: BioFirst Corporation
• Collaborators: ABVC BioPharma, Inc
• Investigators: Study Director: Richard CH King, Ph.D., ABVC BioPharma, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment
• Other Study ID Numbers: ABV-1701-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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