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New eye drug BBC1501 enters first human safety trial for blinding disease

NCT ID NCT05803785

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

50 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Benobio Investigational site

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2000, Australia

  • Sydney Hospital

    RECRUITING

    Sydney, Australia

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