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对先前接受过除雷珠单抗以外的玻璃体内药物治疗的新生血管性年龄相关性黄斑变性患者过渡到雷珠单抗 [Susvimo（雷珠单抗注射液）] 端口输送系统后治疗反应的研究 (Belvedere)

2026年11月2日 更新者：Genentech, Inc.

一项 IV 期、多中心、开放标签、单臂研究，研究过渡到使用雷珠单抗 [Susvimo（雷珠单抗注射液）] 的端口输送系统后对先前接受过玻璃体内药物治疗的新生血管性年龄相关性黄斑变性患者的治疗反应 其他比雷珠单抗

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (估计的)

188

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Mesa、Arizona、美国、85206-2747
        • Barnet Dulaney Perkins Eye Center
    • California
      • Bakersfield、California、美国、93309
        • California Retina Consultants
      • Huntington Beach、California、美国、92647
        • Retina Associates of Southern California
      • Pasadena、California、美国、91107-3747
        • California Eye Specialists Medical group Inc.
      • Sacramento、California、美国、95841-2013
        • Retinal Consultants Med Group
      • San Francisco、California、美国、94158-2510
        • University of California San Francisco
      • Santa Ana、California、美国、92705-6504
        • Orange County Retina Med Group
      • Torrance、California、美国、90503-3270
        • Macula Retina Vitreous Research Institute
    • Colorado
      • Durango、Colorado、美国、81303
        • Southwest Retina Consultants
      • Longmont、Colorado、美国、80503-6499
        • Advanced Vision Research Institute
    • Florida
      • Pensacola、Florida、美国、32503-2030
        • Retina Specialty Institute
      • St. Petersburg、Florida、美国、33711-1141
        • Retina Vitreous Associates of Florida
    • Georgia
      • Augusta、Georgia、美国、30909-6440
        • Southeast Retina Center
    • Illinois
      • Lemont、Illinois、美国、60439-7421
        • University Retina and Macula Associates, PC
    • Maine
      • Portland、Maine、美国、04101
        • Maine Eye Center
    • Maryland
      • Baltimore、Maryland、美国、21287-0005
        • Wilmer Eye Institute Johns Hopkins University
      • Baltimore、Maryland、美国、21209-2219
        • The Retina Care Center
      • Hagerstown、Maryland、美国、21740
        • Cumberland Valley Retina Consultants PC
    • Michigan
      • Royal Oak、Michigan、美国、48073
        • Associated Retinal Consultants PC
    • Minnesota
      • Minneapolis、Minnesota、美国、55435-3004
        • VitreoRetinal Surgery, PLLC.
    • Missouri
      • Chesterfield、Missouri、美国、63017-5065
        • Midwest Vision Research Foundation
    • Nevada
      • Reno、Nevada、美国、89502-1605
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield、New Jersey、美国、07003
        • Envision Ocular, LLC
    • New York
      • Poughkeepsie、New York、美国、12603-2416
        • Seeta Eye Centers
    • North Carolina
      • Durham、North Carolina、美国、27705-4699
        • Duke Eye Center
      • Hickory、North Carolina、美国、28602
        • Graystone Eye-Hickory - 2415 Century Pl
    • North Dakota
      • Fargo、North Dakota、美国、58047
        • Fargo Retina Consultants
    • Ohio
      • Blue Ash、Ohio、美国、45242-5537
        • Cincinnati Eye Institute
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic
    • Pennsylvania
      • Erie、Pennsylvania、美国、16505
        • Erie Retina Research
    • Tennessee
      • Germantown、Tennessee、美国、38138-2405
        • Charles Retina Institute
      • Nashville、Tennessee、美国、37203-1596
        • Tennessee Retina PC
    • Texas
      • Amarillo、Texas、美国、79106-1835
        • Panhandle Eye Group LLP Southwest Retina Specialists
      • Austin、Texas、美国、78750-2298
        • Austin Clinical Research, LLC
      • Bellaire、Texas、美国、77401
        • Retina Consultants of Texas
      • Schertz、Texas、美国、78154
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City、Utah、美国、84107-6767
        • Retina Associates of Utah, PLLC
    • Virginia
      • Lynchburg、Virginia、美国、24502-4271
        • Piedmont Eye Center
      • Norfolk、Virginia、美国、23502-3933
        • Wagner Kapoor Institute
    • Washington
      • Spokane、Washington、美国、99204-2509
        • Spokane Eye Clinical Research

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

Ocular Inclusion Criteria:

  • Diagnosis of nAMD prior to screening as determined by the investigator

  • Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center

  • Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion

  • Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening

  • Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:

    • Overall decrease in nAMD disease activity detected on historical or screening OCT
    • Stable or improved best-corrected visual acuity (BCVA)

  • BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment

  • All subtypes of nAMD lesions are permissible

  • nAMD lesions at the time of diagnosis must involve the macula

  • Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images

Exclusion Criteria

Prior Ocular Treatment

Study Eye:

  • Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
  • Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
  • Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
  • History of corneal transplant
  • History of conjunctival surgery in the superotemporal quadrant
  • History of intraocular inflammation following anti-VEGF injection

Either Eye:

  • Previous PDS implantation
  • Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
  • Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
  • Prior pars plana vitrectomy surgery
  • Previous intraocular device implantation, excluding intraocular lenses
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
  • Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening
  • Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
  • Contact lens wear in either eye within 2 months of screening
  • Any prior penetrating ocular trauma
  • Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening
  • History of corneal transplantation, including partial-thickness corneal grafts
  • Prior treatment with brolucizumab
  • Prior treatment with external-beam radiation therapy or brachytherapy
  • History of hypersensitivity to ranibizumab or any excipients of Susvimo

Macular Neovascularization Lesion (MNV) Characteristics

Study Eye:

  • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area [1.27 square millimeters (mm^2)] in size
  • Subfoveal fibrosis or subfoveal atrophy

Either Eye:

  • MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)

Current or Historical Ocular Conditions

Study Eye:

  • Retinal pigment epithelial tear
  • Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
  • Current vitreous hemorrhage
  • Current or history of retinal detachment
  • Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
  • Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination
  • Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
  • Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
  • Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery
  • Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
  • Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
  • Conjunctival pathologies in the superotemporal quadrant
  • History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
  • Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
  • Trichiasis
  • Corneal neuropathy
  • Lagophthalmos or incomplete blink
  • Active or history of facial nerve palsy/paresis

Fellow (Non-Study) Eye:

• Concurrent or history of PDS implantation

Either Eye:

  • Aphakia or absence of the posterior capsule
  • Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
  • Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center
  • Fuchs endothelial corneal dystrophy Grade ≥ 2
  • Previous corneal endothelial cell damage, including from blunt or surgical trauma
  • Any ocular condition that precludes obtaining an analyzable specular microscopy image
  • Active or history of corneal edema
  • Active or history of corneal dystrophies
  • Active or history of iridocorneal endothelial syndrome
  • Active or history of pseudoexfoliation syndrome
  • Active or history of herpetic keratitis or kerato-uveitis
  • Any active or history of uveitis
  • Active intraocular inflammation
  • Active or history of keratitis, scleritis, or endophthalmitis
  • Active ocular or periocular infection
  • Active or history of Sjogren's syndrome or keratoconjunctivitis sicca
  • Active or history of floppy eyelid syndrome
  • Active or history of chronic eye rubbing
  • Active thyroid eye disease

Concurrent Systemic Conditions:

  • History of uncontrolled blood pressure
  • Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegener's)
  • History of stroke within the last 3 months prior to screening
  • Uncontrolled atrial fibrillation within 3 months of screening
  • History of myocardial infarction within the last 3 months prior to screening
  • History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator
  • Current active systemic infection
  • Use of any systemic anti-VEGF agents
  • Chronic use of oral corticosteroids
  • Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for > 12 months
  • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)
  • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit
  • Requirement for continuous use of any medications or treatments indicated as prohibited therapy
  • Pregnant or breastfeeding, or intention to become pregnant during the study
  • Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：SUSVIMO

Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres [uL] of the 100 milligrams/millilitres [mg/ml] formulation of ranibizumab [approximately 2 milligrams (mg) dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
设备：PDS Implant With Ranibizumab 100 mg/ml

Ranibizumab 100 mg/mL will be delivered via PDS

药品：LUCENTIS (Ranibizumab Injection)

Ranibizumab (0.5 mg intravitreal [IVT] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
通过镜面显微镜评估，与对侧眼相比，第 48 周时研究眼的角膜内皮细胞密度 (ECD) 相对于基线的变化百分比
大体时间：基线，第 48 周
基线，第 48 周

次要结果测量

结果测量
措施说明
大体时间
与另一眼相比，第 24 周时研究眼的角膜 ECD 相对于基线的变化百分比
大体时间：基线，第 24 周
基线，第 24 周
与另一眼相比，第 24 周和第 48 周时研究眼的角膜内皮细胞面积变异系数 (CV) 相对于基线的百分比变化
大体时间：基线、第 24 周、第 48 周
基线、第 24 周、第 48 周
与对侧眼相比，研究眼在第 24 周和第 48 周时六角形细胞 (HEX) 相对于基线的变化百分比
大体时间：基线、第 24 周、第 48 周
基线、第 24 周、第 48 周
患有眼部严重不良事件 (SAE) 的参与者的百分比以及 SAE 的严重程度
大体时间：第 1 天至第 52 周左右
第 1 天至第 52 周左右
患有特殊兴趣眼部不良事件 (AESI) 的参与者的百分比以及眼部 AESI 的严重程度
大体时间：第 1 天至第 52 周
第 1 天至第 52 周
眼部 AESI 持续时间
大体时间：第 1 天至第 52 周
第 1 天至第 52 周
术后期间患有眼部 AESI 的参与者的百分比
大体时间：初始植入后长达 37 天的基线
初始植入后长达 37 天的基线
术后中期患有眼部 AESI 的参与者的百分比
大体时间：植入后 38 至 93 天
植入后 38 至 93 天
患有器械不良反应 (ADE) 的参与者的百分比
大体时间：第 1 天至第 52 周
第 1 天至第 52 周
预期出现严重器械不良反应 (ASADE) 的参与者数量以及 ASADE 的严重程度
大体时间：第 1 天至第 52 周
第 1 天至第 52 周
ASADE 的持续时间
大体时间：第 1 天至第 52 周
第 1 天至第 52 周
Percentage of Participants With Ocular AESIs During the Follow-up Period
大体时间：Week 52

The investigator will follow each adverse event (AE) until the event has resolved to baseline grade or better, the event is assessed as stable by the investigator, the participant is lost to follow-up, or the participant withdraws consent.
Week 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Genentech, Inc.

调查人员

  • 研究主任：Clinical Trials、Genentech, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年12月14日

初级完成 (估计的)

2027年7月30日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2021年4月16日

首先提交符合 QC 标准的

2021年4月16日

首次发布 (实际的)

2021年4月21日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ML43000

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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