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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05803785




Registration number
NCT05803785
Ethics application status
Date submitted
12/03/2023
Date registered
7/04/2023
Date last updated
14/12/2023

Titles & IDs
Public title
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Scientific 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)
Secondary ID [1] 0 0
BBRP11001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 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: Drugs - BBC1501

Experimental: BBC1501 1.25ug - Cohort 1; open-label, non-randomized, single administration

Experimental: BBC1501 2.5ug - Cohort 2; open-label, non-randomized, single administration

Experimental: BBC1501 5ug - Cohort 3; open-label, non-randomized, single administration


Treatment: Drugs: BBC1501
BBC1501 solution for Intravitreal injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessment of ophthalmic and systemic TEAEs, during study period
Timepoint [1] 0 0
Every week up to 4 weeks
Primary outcome [2] 0 0
Assessment of ophthalmic and systemic TEAEs, during study period
Timepoint [2] 0 0
every 4 weeks up to 12 weeks
Secondary outcome [1] 0 0
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Timepoint [1] 0 0
Baseline, Week4
Secondary outcome [2] 0 0
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Timepoint [2] 0 0
Baseline, Week12
Secondary outcome [3] 0 0
Change in CNV size according to fluorescein angiogram
Timepoint [3] 0 0
Baseline, Week4
Secondary outcome [4] 0 0
Change in CNV size according to fluorescein angiogram
Timepoint [4] 0 0
Baseline, Week12
Secondary outcome [5] 0 0
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Timepoint [5] 0 0
Baseline, Week4
Secondary outcome [6] 0 0
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Timepoint [6] 0 0
Baseline, Week12
Secondary outcome [7] 0 0
Number of patients who initiation of rescue therapy during study
Timepoint [7] 0 0
Week1, Week12

Eligibility
Key inclusion criteria
Key

- 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.

- Participants who have failed prior treatment in the study eye with any IVT anti VEGF
medication with a washout period of four weeks prior to first administration of the
IMP who in the opinion of the investigator, have disease sufficiently stable to enable
this interval.

Key
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

- 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).

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Benobio Investigational site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Benobio Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05803785
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Inhyun Lee, ph.D
Address 0 0
Benobio Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
jihye choe
Address 0 0
Country 0 0
Phone 0 0
+827046675278
Fax 0 0
Email 0 0
jihye.choe@benobio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05803785