Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BBC1501 1.25ug Cohort 1; open-label, non-randomized, single administration |
Drug: BBC1501
BBC1501 solution for Intravitreal injection
|
| Experimental: BBC1501 2.5ug Cohort 2; open-label, non-randomized, single administration |
Drug: BBC1501
BBC1501 solution for Intravitreal injection
|
| Experimental: BBC1501 5ug Cohort 3; open-label, non-randomized, single administration |
Drug: BBC1501
BBC1501 solution for Intravitreal injection
|
Outcome Measures
Primary Outcome Measures
- Assessment of ophthalmic and systemic TEAEs, during study period [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 [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.
Secondary Outcome Measures
- Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline [Baseline, Week4]
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
- Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline [Baseline, Week12]
Assessment ETDRS change from baseline by Optical Coherence Tomography(OCT)
- Change in CNV size according to fluorescein angiogram [Baseline, Week4]
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
- Change in CNV size according to fluorescein angiogram [Baseline, Week12]
Assessment CNV size change from baseline by Fundus fluorescein angiography(FFA)
- Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume [Baseline, Week4]
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Changes in intra-or sub-retinal fluid measured as mean change in central retinal thickness or macula volume [Baseline, Week12]
Assessment Central retinal thickness from baseline by Spectral Domain Optical Coherence Tomography (SD-OCT)
- Number of patients who initiation of rescue therapy during study [Week1, Week12]
Exploratory using rescue therapy during study and follow-up period
Eligibility Criteria
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.
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Male or female aged ≥ 50 years.
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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.
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Presence of intra and/or subretinal fluid as identified by SD-OCT (or SS-OCT) attributable to active CNV in the study eye.
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Central retinal thickness (CRT) of ≥ 300 μm in the study eye as determined by SD- OCT (SS-OCT) at screening.
Key Exclusion Criteria:
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Prior treatment in the study eye with any intravitreal anti-VEGF medication within the past 3 month prior to the Screening visit.
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Use of any of the following treatments or anticipated use of any of the following treatments to the study eye:
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Intravitreal or periocular corticosteroid, within 90 days prior to Visit 1 (Day
- and throughout the study
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BCVA worse than 20/400 in study eye; worse than 20/200 in fellow eye .
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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.
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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).
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History of vitrectomy in the study eye.
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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 (Day 1) in the study eye.
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Intraocular surgery, including lens removal or laser, within 90 days prior to Visit 1 (Day 1) in the study eye.
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Ocular or periocular infection in either eye.
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Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye.
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Media opacity that would limit clinical visualization, intravenous fluorescein angiography, or spectral-domain optical coherence tomography (SD-OCT) evaluation in the study eye.
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History of herpetic infection in the study eye or adnexa.
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Presence of known active toxoplasmosis, inactive toxoplasmosis or toxoplasmosis scar in either eye.
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Presence of any form of ocular malignancy including choroidal melanoma in either eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Benobio Investigational site | Malvern | Victoria | Australia | 3144 |
| 2 | Benobio Investigational site | Saint Albans | Victoria | Australia | 3021 |
Sponsors and Collaborators
- Benobio Co., Ltd.
Investigators
- Study Chair: Inhyun Lee, ph.D, Benobio Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BBRP11001-101