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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Sydney Hospital
  Sydney, Australia Recruiting
• Benobio Investigational site
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Study coordinator: jihye choe
• Email: jihye.choe@benobio.com
• Phone: +827046675278

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding Age-Related Macular Degeneration and Its Progression

  This study looks at how age-related macular degeneration develops and progresses by comparing people with the condition to healthy individuals, using non-invasive tests and personal feedback.

  Recruiting Center for Eye Research Australia · East Melbourne, Victoria · NCT04739319

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

  This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul · NCT07821450

• First-in-human test of ARO-033 in adults

  This study tests whether ARO-033 is safe and tolerable, and how it behaves in the body, in healthy adults and in adults with age-related macular degeneration.

  Recruiting Phase 1 Arrowhead Pharmaceuticals · Auckland · NCT07662096

• Predicting Risk of AMD Progression Using Imaging in Aging Eyes

  Researchers are test a new screening approach to detect early AMD and monitor its progression in adults 55 and older, to see if personalized monitoring can help in community settings.

  Recruiting at 2 sites Singapore National Eye Centre · Singapore and 1 other locations · NCT07653269

• C.001 for retinal degeneration: a first-in-human dose-escalation safety test

  A first-in-human study will test the safety and tolerability of a single subretinal injection of C.001 in adults with retinal diseases involving retinal pigment epithelium degeneration.

  Recruiting at 2 sites Phase 1 Cellio Therapeutics Inc · Beverly Hills, California and 2 other locations · NCT07594236

• Central microperimetry and radial OCT in geographic atrophy

  We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07556406

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.