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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат BBC1501
  BBC1501 solution for Intravitreal injection

Первичные конечные точки

• Assessment of ophthalmic and systemic TEAEs, during study period [Срок оценки: Every week up to 4 weeks]
• Assessment of ophthalmic and systemic TEAEs, during study period [Срок оценки: every 4 weeks up to 12 weeks]

Вторичные конечные точки (3)

• Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline [Срок оценки: Baseline, Week4]
• Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA from baseline [Срок оценки: Baseline, Week12]
• Number of patients who initiation of rescue therapy during study [Срок оценки: Week1, Week12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 2 центра

• Benobio Investigational site — Sydney
• Sydney Hospital — Sydney

Идентификаторы

NCT: NCT05803785 · BBRP11001-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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