Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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)
Query!
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)
Query!
Secondary ID [1]
0
0
BBRP11001-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration
0
0
Query!
Condition category
Condition code
Eye
0
0
0
0
Query!
Diseases / disorders of the eye
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Assessment of ophthalmic and systemic TEAEs, during study period
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Every week up to 4 weeks
Query!
Primary outcome [2]
0
0
Assessment of ophthalmic and systemic TEAEs, during study period
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
every 4 weeks up to 12 weeks
Query!
Secondary outcome [1]
0
0
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Query!
Assessment method [1]
0
0
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Query!
Timepoint [1]
0
0
Baseline, Week4
Query!
Secondary outcome [2]
0
0
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Query!
Assessment method [2]
0
0
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Query!
Timepoint [2]
0
0
Baseline, Week12
Query!
Secondary outcome [3]
0
0
Change in CNV size according to fluorescein angiogram
Query!
Assessment method [3]
0
0
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Query!
Timepoint [3]
0
0
Baseline, Week4
Query!
Secondary outcome [4]
0
0
Change in CNV size according to fluorescein angiogram
Query!
Assessment method [4]
0
0
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
Query!
Timepoint [4]
0
0
Baseline, Week12
Query!
Secondary outcome [5]
0
0
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Query!
Assessment method [5]
0
0
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Query!
Timepoint [5]
0
0
Baseline, Week4
Query!
Secondary outcome [6]
0
0
Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
Query!
Assessment method [6]
0
0
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
Query!
Timepoint [6]
0
0
Baseline, Week12
Query!
Secondary outcome [7]
0
0
Number of patients who initiation of rescue therapy during study
Query!
Assessment method [7]
0
0
Exploratory using rescue therapy during study and follow-up period
Query!
Timepoint [7]
0
0
Week1, Week12
Query!
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
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/01/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/10/2024
Query!
Actual
Query!
Sample size
Target
18
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Benobio Investigational site - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2000 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Benobio Co., Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05803785
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Inhyun Lee, ph.D
Query!
Address
0
0
Benobio Co., Ltd.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
jihye choe
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+827046675278
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05803785
Download to PDF