Clinical trial NCT05803785: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Lead sponsor: Benobio Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.
* 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 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

Primary outcomes:
measure: Assessment of ophthalmic and systemic TEAEs, during study period
timeFrame: Every week up to 4 weeks
measure: Assessment of ophthalmic and systemic TEAEs, during study period
timeFrame: every 4 weeks up to 12 weeks
Secondary outcomes:
measure: Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
timeFrame: Baseline, Week4
measure: Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
timeFrame: Baseline, Week12
measure: Number of patients who initiation of rescue therapy during study
timeFrame: Week1, Week12
Other outcomes:
measure: Change in CNV size according to fluorescein angiogram
timeFrame: Baseline, Week4
measure: Change in CNV size according to fluorescein angiogram
timeFrame: Baseline, Week12
measure: Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
timeFrame: Baseline, Week4
measure: Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume
timeFrame: Baseline, Week12
Locations:
city: Sydney
country: Australia
facility: Benobio Investigational site
state: New South Wales
Study officials:
affiliation: Benobio Co., Ltd.
name: Inhyun Lee, ph.D
role: STUDY_CHAIR
References: