New eye drug BBC1501 enters first human safety trial for blinding disease
NCT ID NCT05803785
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental drug called BBC1501, given as an injection into the eye, for people with wet age-related macular degeneration (nAMD). The main goal is to check safety and tolerability in 18 volunteers aged 50 and older who have already received standard treatment. Researchers will also look for early signs of benefit, but the primary focus is on whether the drug is safe enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BBC1501 (an experimental drug injected into the eye)
- What this could lead to
- If safe and effective, BBC1501 could offer a new treatment option for wet age-related macular degeneration, potentially reducing the need for frequent eye injections.
- What could go wrong
- This is a very early, small Phase 1 trial with only 18 participants, focused on safety. It is not designed to prove the drug works, and many early-stage drugs fail to show benefit or have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Benobio Investigational site
NOT_YET_RECRUITINGSydney, New South Wales, 2000, Australia
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Sydney Hospital
RECRUITINGSydney, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer eye injections dry the retina in wet AMD?
- The 20-Minute squeeze: how eye injections push pressure up
- Could years of eye injections weigh down the upper eyelid?
- One shot in the eye: gene therapy aims to replace repeated injections for wet AMD
- Can blocking rogue immune cells stop a leading cause of blindness?
- Can a One-Time gene injection ease the burden of wet AMD?