Safety of BBC1501 intravitreal injection for people with neovascular age-related macular degeneration

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)

BBC1501 injected into the eye will be tested for safety and tolerability in people 50 and older with wet AMD who have not responded to at least two prior anti-VEGF treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Benobio Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Sydney, New South Wales and 1 other locations)
• Trial ID: NCT05803785 on ClinicalTrials.gov

What this trial studies

This is an open-label Phase 1 study using three ascending intravitreal doses of BBC1501 to primarily measure safety and tolerability in eyes with active neovascular AMD. Eligible participants must have active CNV confirmed by OCT and angiography, central subfield thickness ≥300 µm, and visual acuity roughly between 20/60 and 20/400 in the study eye. Participants will have had at least a six-week washout from prior intravitreal anti‑VEGF drugs and are selected because they were judged non-responders to at least two prior treatments. Secondary, exploratory outcomes will collect early signals of efficacy such as changes in retinal fluid, central thickness, and visual acuity over the follow-up period.

Who should consider this trial

Good fit: Adults aged 50 or older with active CNV from nAMD, central subfield thickness ≥300 µm, BCVA approximately 20/60 to 20/400 (or 21–60 ETDRS letters) in the study eye, and judged non-responders to at least two prior anti-VEGF injections are the ideal candidates.

Not a fit: Patients who currently respond well to standard anti-VEGF therapy, have better-than-specified vision, or have other ocular conditions likely to limit visual recovery may not benefit from joining this study.

Why it matters

Potential benefit: If safe and effective, BBC1501 could provide a new treatment option for patients with nAMD who have not responded to existing anti-VEGF therapies and might reduce retinal fluid and stabilize vision.

How similar studies have performed: Other intravitreal biologics and next-generation anti-VEGF approaches have shown benefits for some nAMD patients, but BBC1501 itself is being tested for the first time in humans in this early safety study.

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

Where this trial is running

Sydney, New South Wales and 1 other locations

• Benobio Investigational site — Sydney, New South Wales, Australia (Not_yet_recruiting)
• Sydney Hospital — Sydney, Australia (Recruiting)

Study contacts

• Study coordinator: jihye choe

Conditions Age-Related Macular Degeneration