NCT05803785 Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
| NCT ID | NCT05803785 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Benobio Co., Ltd. |
| Condition | Age-Related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. * 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
Contact & Investigator
Inhyun Lee, ph.D
STUDY CHAIR
Benobio Co., Ltd.
Frequently Asked Questions
Who can join the NCT05803785 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05803785 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05803785 currently recruiting?
Yes, NCT05803785 is actively recruiting participants. Contact the research team at jihye.choe@benobio.com for enrollment information.
Where is the NCT05803785 trial being conducted?
This trial is being conducted at Sydney, Australia, Sydney, Australia.
Who is sponsoring the NCT05803785 clinical trial?
NCT05803785 is sponsored by Benobio Co., Ltd.. The principal investigator is Inhyun Lee, ph.D at Benobio Co., Ltd.. The trial plans to enroll 18 participants.