Age-Related Macular DegenerationPhase 1NCT05803785
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
A Phase 1 study testing BBC1501 in people with Age-Related Macular Degeneration, run by Benobio Co., Ltd. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- BBC1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Jul 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Not yet recruiting
Benobio Investigational site
Sydney, New South Wales, 2000
jihye choe, jihye.choe@benobio.com
- Recruiting
Sydney Hospital
Sydney
About this study
Official title: 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)
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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- BBC1501
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBC1501Drug
BBC1501 solution for Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| BBC1501 1.25ug | Experimental | Cohort 1; open-label, non-randomized, single administration Receives: Drug: BBC1501 |
| BBC1501 2.5ug | Experimental | Cohort 2; open-label, non-randomized, single administration Receives: Drug: BBC1501 |
| BBC1501 5ug | Experimental | Cohort 3; open-label, non-randomized, single administration Receives: Drug: BBC1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Measured: Every week up to 4 weeks
Assessment of ophthalmic and systemic TEAEs, during study period
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Measured: every 4 weeks up to 12 weeks
Secondary outcomes (3)
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Measured: Baseline, Week4
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
Measured: Baseline, Week12
Number of patients who initiation of rescue therapy during study
Exploratory using rescue therapy during study and follow-up period
Measured: Week1, Week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benobio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Inhyun Lee, ph.D, Study chair, Benobio Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803785
- Sponsor's protocol ID
- BBRP11001-101
- Status last verified
- May 2026
- First submitted
- 12 Mar 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05803785
- Acronym / sponsor ID
- BBRP11001-101
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Benobio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BBC1501 1.25ug | Experimental | Drug: BBC1501Cohort 1; open-label, non-randomized, single administration |
| BBC1501 2.5ug | Experimental | Drug: BBC1501Cohort 2; open-label, non-randomized, single administration |
| BBC1501 5ug | Experimental | Drug: BBC1501Cohort 3; open-label, non-randomized, single administration |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBC1501BBC1501 solution for Intravitreal injection | Drug | BBC1501 1.25ug, BBC1501 2.5ug, BBC1501 5ug |
Primary outcome
Assessment of ophthalmic and systemic TEAEs, during study period
Time frame: Every week up to 4 weeks
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 4 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
Assessment of ophthalmic and systemic TEAEs, during study period
Time frame: every 4 weeks up to 12 weeks
To evaluate the safety and tolerability of a single IVT dose of BBC1501 at 12 weeks after dose.To characterize ocular and non-ocular safety by the incidence of treatment-emergent adverse events (AEs) (new or worsening from baseline) summarized categorically by system organ class and/or preferred term.
3 secondary outcomes
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Time frame: Baseline, Week4
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline
Time frame: Baseline, Week12
Number of patients who initiation of rescue therapy during study
Time frame: Week1, Week12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inhyun Lee, ph.D study chair
Benobio Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBC1501 in people with Age-Related Macular Degeneration, run by Benobio Co., Ltd. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jihye choe (+827046675278, jihye.choe@benobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ophthalmic and systemic TEAEs, during study period (time frame: Every week up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.