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Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Primary Purpose

Age-Related Macular Degeneration

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BBC1501
Sponsored by
Benobio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Able to provide voluntary written informed consent on the approved ICF, understand the study requirements, and are willing to follow and complete all the study required procedures. Male or female aged ≥ 50 years. Diagnosed with nAMD in the study eye as confirmed by fundus fluorescein angiography (FFA). Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye. Best corrected visual acuity (BCVA) between 73 and 34 letters, inclusive, in the study eye using ETDRS testing. Presence of intra and/or subretinal fluid as identified by SD-OCT (or SS-OCT) attributable to active CNV in the study eye. Central retinal thickness (CRT) of ≥ 300 μm in the study eye as determined by SD- OCT (SS-OCT) at screening. Participants who have had prior treatment in the study eye with any IVT anti VEGF medication with a washout period of three months prior to the Screening visit. Key Exclusion Criteria: Use of any of the following treatments or anticipated use of any of the following treatments to the study eye: Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study BCVA worse than 20/400 in study eye; worse than 20/200 in fellow eye . Uncontrolled or advanced glaucoma, evidenced by an IOP of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye. Evidence of any other ocular disease other than nAMD in the study eye that may confound the outcome of the study (eg, active diabetic retinopathy, posterior uveitis, pseudovitelliform macular degeneration, moderate/severe myopia). History of vitrectomy in the study eye. Need for ocular surgery in the study eye during the course of the study. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye. Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye. Ocular or periocular infection in either eye. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye. Media opacity that would limit clinical visualization, intravenous fluorescein angiography, or spectral-domain optical coherence tomography (SD-OCT) evaluation in the study eye. History of herpetic infection in the study eye or adnexa. Presence of known active toxoplasmosis, inactive toxoplasmosis or toxoplasmosis scar in either eye. Presence of any form of ocular malignancy including choroidal melanoma in either eye

Sites / Locations

  • Benobio Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BBC1501 1.25ug

BBC1501 2.5ug

BBC1501 5ug

Arm Description

Cohort 1; open-label, non-randomized, single administration

Cohort 2; open-label, non-randomized, single administration

Cohort 3; open-label, non-randomized, single administration

Outcomes

Primary Outcome Measures

Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.

Secondary Outcome Measures

Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Change in CNV size according to fluorescein angiogram
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Change in CNV size according to fluorescein angiogram
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Number of patients who initiation of rescue therapy during study
Exploratory using rescue therapy during study and follow-up period

Full Information

First Posted
March 12, 2023
Last Updated
October 11, 2023
Sponsor
Benobio Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05803785
Brief Title
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Official Title
A Phase 1, Open Label, Ascending Dose Study to Evaluate the Safety of BBC1501 Administered by Intravitreal Injection for Neovascular Age-Related Macular Degeneration (nAMD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benobio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This open-label study is being conducted to evaluate the initial safety and tolerability of BBC1501 IVT in patients with nAMD. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of IVT BBC1501 in patients with nAMD. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BBC1501 1.25ug
Arm Type
Experimental
Arm Description
Cohort 1; open-label, non-randomized, single administration
Arm Title
BBC1501 2.5ug
Arm Type
Experimental
Arm Description
Cohort 2; open-label, non-randomized, single administration
Arm Title
BBC1501 5ug
Arm Type
Experimental
Arm Description
Cohort 3; open-label, non-randomized, single administration
Intervention Type
Drug
Intervention Name(s)
BBC1501
Intervention Description
BBC1501 solution for Intravitreal injection
Primary Outcome Measure Information:
Title
Assessment of ophthalmic and systemic TEAEs, during study period
Description
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Time Frame
Every week up to 4 weeks
Title
Assessment of ophthalmic and systemic TEAEs, during study period
Description
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Time Frame
every 4 weeks up to 12 weeks
Secondary Outcome Measure Information:
Title
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Description
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Time Frame
Baseline, Week4
Title
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Description
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Time Frame
Baseline, Week12
Title
Change in CNV size according to fluorescein angiogram
Description
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Time Frame
Baseline, Week4
Title
Change in CNV size according to fluorescein angiogram
Description
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Time Frame
Baseline, Week12
Title
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Description
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time Frame
Baseline, Week4
Title
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Description
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time Frame
Baseline, Week12
Title
Number of patients who initiation of rescue therapy during study
Description
Exploratory using rescue therapy during study and follow-up period
Time Frame
Week1, Week12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Able to provide voluntary written informed consent on the approved ICF, understand the study requirements, and are willing to follow and complete all the study required procedures. Male or female aged ≥ 50 years. Diagnosed with nAMD in the study eye as confirmed by fundus fluorescein angiography (FFA). Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye. Best corrected visual acuity (BCVA) between 73 and 34 letters, inclusive, in the study eye using ETDRS testing. Presence of intra and/or subretinal fluid as identified by SD-OCT (or SS-OCT) attributable to active CNV in the study eye. Central retinal thickness (CRT) of ≥ 300 μm in the study eye as determined by SD- OCT (SS-OCT) at screening. Participants who have had prior treatment in the study eye with any IVT anti VEGF medication with a washout period of three months prior to the Screening visit. Key Exclusion Criteria: Use of any of the following treatments or anticipated use of any of the following treatments to the study eye: Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day 1) and throughout the study BCVA worse than 20/400 in study eye; worse than 20/200 in fellow eye . Uncontrolled or advanced glaucoma, evidenced by an IOP of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, or chronic hypotony (< 6 mmHg) in the study eye. Evidence of any other ocular disease other than nAMD in the study eye that may confound the outcome of the study (eg, active diabetic retinopathy, posterior uveitis, pseudovitelliform macular degeneration, moderate/severe myopia). History of vitrectomy in the study eye. Need for ocular surgery in the study eye during the course of the study. YAG laser capsulotomy within 30 days prior to Visit 1 (Day 1) in the study eye. Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye. Ocular or periocular infection in either eye. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye. Media opacity that would limit clinical visualization, intravenous fluorescein angiography, or spectral-domain optical coherence tomography (SD-OCT) evaluation in the study eye. History of herpetic infection in the study eye or adnexa. Presence of known active toxoplasmosis, inactive toxoplasmosis or toxoplasmosis scar in either eye. Presence of any form of ocular malignancy including choroidal melanoma in either eye
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jihye choe
Phone
+827046675278
Email
jihye.choe@benobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inhyun Lee, ph.D
Organizational Affiliation
Benobio Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Benobio Investigational site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

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