Actively Recruiting
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Led by Benobio Co., Ltd. · Updated on 2025-07-08
18
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide voluntary written informed consent and willing to complete all study procedures
- Male or female aged 50 years or older
- Non-responders to at least 2 prior anti-VEGF treatments for nAMD in the study eye
- Active choroidal neovascularization lesions secondary to nAMD confirmed by SD-OCT (or SS-OCT), fluorescein angiography, and fundus photography in the study eye
- Best corrected visual acuity between 60 and 21 letters inclusive by ETDRS or between 20/60 and 20/400 inclusive by Snellen chart in the study eye
- Central subfield thickness of at least 300 micrometers with presence of intraretinal and/or subretinal fluid
- Had a washout period of at least six weeks from any prior intravitreal anti-VEGF medication with stable disease as judged by the investigator
You will not qualify if you...
- Use of intravitreal or periocular corticosteroids within 90 days prior to study start or planned use during the study in the study eye
- Glaucoma with intraocular pressure greater than 21 mmHg or chronic hypotony less than 6 mmHg in the study eye
- Any other ocular disease in the study eye that may affect study results (eg, active diabetic retinopathy, posterior uveitis, pseudovitelliform macular degeneration, moderate/severe myopia)
- Advanced nAMD with no visual acuity prognosis as judged by the investigator
- Need for ocular surgery in the study eye during the study
- YAG laser capsulotomy within 30 days prior to study start in the study eye
- Intraocular surgery including lens removal or laser within 90 days prior to study start in the study eye
- Ocular or periocular infection in either eye
- Pupillary dilation inadequate for quality fundus photography in the study eye
- Media opacity limiting visualization or imaging evaluations in the study eye
- History of herpetic infection in the study eye or surrounding areas
- Presence of active or inactive toxoplasmosis or toxoplasmosis scar in either eye
- Any form of ocular malignancy including choroidal melanoma in either eye
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Benobio Investigational site
Sydney, New South Wales, Australia, 2000
Not Yet Recruiting
2
Sydney Hospital
Sydney, Australia
Actively Recruiting
Research Team
J
jihye choe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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