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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: BBC1501

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: jihye choe; Phone Number: +827046675278; Email: jihye.choe@benobio.com

Study Locations

• Australia
  • Sydney, Australia
    • Recruiting
    • Sydney Hospital
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Not yet recruiting
      • Benobio Investigational site
      • Contact: jihye choe; Email: jihye.choe@benobio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• As per the Investigator's judgment, patients with active CNV lesions (ie, foveal or parafoveal) secondary to nAMD, as confirmed with SD-OCT, FFA, and fundus photography (FP) in the study eye. Patients must have received at least two prior anti-VEGF doses (eg, aflibercept, ranibizumab, bevacizumab, brolicizumab, or faricimab), meeting criteria for non-ideal response
• Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye.
• BCVA score of between 73 and 21 letters, inclusive, in the study eye using ETDRS testing (Snellen equivalent score between 20/40 and 20/400, inclusive
• Participant has CST > 250 μm if measured by Cirrus OCT or > 270 μm if measured by Spectralis OCT, 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 despite up to 4 glaucoma medications, or evidence of glaucomatous visual field loss or has advanced glaucoma (e.g., prior shunt surgery) in either 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 in the study eye.
• Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBC1501 1.25ug; Cohort 1; open-label, non-randomized, single administration	Drug: BBC1501; BBC1501 solution for Intravitreal injection
Experimental: BBC1501 2.5ug; Cohort 2; open-label, non-randomized, single administration	Drug: BBC1501; BBC1501 solution for Intravitreal injection
Experimental: BBC1501 5ug; Cohort 3; open-label, non-randomized, single administration	Drug: BBC1501; BBC1501 solution for Intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline	Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)	Baseline, Week4
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline	Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)	Baseline, Week12
Number of patients who initiation of rescue therapy during study	Exploratory using rescue therapy during study and follow-up period	Week1, Week12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CNV size according to fluorescein angiogram	Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)	Baseline, Week4
Change in CNV size according to fluorescein angiogram	Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)	Baseline, Week12
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
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

Collaborators and Investigators

• Sponsor: Benobio Co., Ltd.
• Investigators: Study Chair: Inhyun Lee, ph.D, Benobio Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration
• Other Study ID Numbers: BBRP11001-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No