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

Age-Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05803785
• Other study ID #: BBRP11001-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Benobio Co., Ltd.
• Contact: jihye choe
• Phone: +827046675278
• Email: jihye.choe[@]benobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• BBC1501
BBC1501 solution for Intravitreal injection

Locations

Country	Name	City	State
Australia	Benobio Investigational site	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Benobio Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in CNV size according to fluorescein angiogram	Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)	Baseline, Week4
Other	Change in CNV size according to fluorescein angiogram	Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)	Baseline, Week12
Other	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)	Baseline, Week4
Other	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)	Baseline, Week12
Primary	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.	Every week up to 4 weeks
Primary	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.	every 4 weeks up to 12 weeks
Secondary	Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline	Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)	Baseline, Week4
Secondary	Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline	Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)	Baseline, Week12
Secondary	Number of patients who initiation of rescue therapy during study	Exploratory using rescue therapy during study and follow-up period	Week1, Week12