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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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. The secondary objective of this study is to exploratory of BBC1501 efficacy following 3 ascending dose of BBC1501 in nAMD patient.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benobio Co., Ltd.

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.

• Diagnosed with nAMD in the study eye as confirmed by fundus fluorescein angiography (FFA).

• 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 73 and 34 letters, inclusive, in the study eye using ETDRS testing.

• Presence of intra and/or subretinal fluid as identified by SD-OCT (or SS-OCT) attributable to active CNV in the study eye.

• Central retinal thickness (CRT) of ≥ 300 μm in the study eye as determined by SD- OCT (SS-OCT) at screening.

Key Exclusion Criteria:

• Prior treatment in the study eye with any intravitreal anti-VEGF medication within the past 3 month prior to the Screening visit.

• 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

• BCVA worse than 20/400 in study eye; worse than 20/200 in fellow eye .

• Uncontrolled or advanced glaucoma, evidenced by an IOP of > 21 mmHg or cup/disc ratio > 0.8 while on medical therapy, 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).

• History of vitrectomy in the study eye.

• 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