Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Benobio

Status and phase: Not yet enrolling; Phase 1

Conditions: Age-Related Macular Degeneration

Treatments: Drug: BBC1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT05803785

BBRP11001-101

Details and patient eligibility

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.
• Participants who as per investigator's judgements are non-responders to at least 2 prior anti-VEGF treatment for nAMD in the study eye
• Active CNV lesions, secondary to nAMD as confirmed with SD-OCT (or SS-OCT), FFA and fundus photography (FP) in the study eye.
• Best corrected visual acuity (BCVA) between 60 and 21 letters, inclusive, in the study eye using ETDRS testing or BCVA between 20/60 and 20/400 letters, inclusive, in the study eye by Snellen chart
• Participant has CST of at least 300 uM 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, or chronic hypotony (< 6 mmHg) in the study 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 (Day 1) in the study eye.
• Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

BBC1501 1.25ug

Experimental group

Description:

Cohort 1; open-label, non-randomized, single administration

Treatment:

Drug: BBC1501

BBC1501 2.5ug

Experimental group

Description:

Cohort 2; open-label, non-randomized, single administration

Treatment:

Drug: BBC1501

BBC1501 5ug

Experimental group

Description:

Cohort 3; open-label, non-randomized, single administration

Treatment:

Drug: BBC1501