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Trial details imported from ClinicalTrials.gov

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




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

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
Number of patients who initiation of rescue therapy during study
Timepoint [3] 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.
* Participants who as per investigator's judgements are non-responders to at least 2 prior anti-VEGF treatment for nAMD in the study eye
* 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 60 and 21 letters, inclusive, in the study eye using ETDRS testing or BCVA between 20/60 and 20/400 letters, inclusive, in the study eye by Snellen chart
* Participant has CST of at least 300 uM with presence of intraretinal and/or subretinal fluid
* Participants who have had a washout period of at least six weeks prior to first administration of the IMP for any IVT anti-VEGF medication and, 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.
* Glaucoma, evidenced by an IOP of > 21 mmHg, 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).
* Participants with advanced nAMD and no prognosis of BCVA as per Investigator's judgement (e.g. due to macular OCT signs of atrophy or photoreceptors disruption, or macular/foveal subretinal hemorrhage).
* 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
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05803785