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Faricimab + PRP与玻璃体切除术 +内溶剂治疗PDR (AP)

2026年9月15日 更新者：Jaeb Center for Health Research

评估 Faricimab + PRP 组合与玻璃体切除术 + Endolaser 组合治疗增殖性糖尿病视网膜病变的随机临床试验

This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Although some combination of anti-VEGF plus PRP is the most common treatment approach for PDR with and without DME, there are currently no long-term data on a standardized approach. Vitrectomy is not currently used as first-line treatment for early PDR but advances in surgical technique have reduced associated complications and the ability to remove the posterior hyaloid during surgery may have advantages over nonsurgical approaches, especially in the reduction of vitreous hemorrhage and/or traction retinal detachment that may occur later when the hyaloid separates naturally. Protocol S demonstrated both PRP and anti-VEGF alone result in good visual acuity results long-term so it is expected that a combination treatment would also result in good visual acuity results.

This study will evaluate the safety and efficacy of two treatment strategies for PDR: faricimab plus PRP and Vitrectomy with endolaser with the goal to determine whether either approach decreases visit and treatment burden along with decreasing complications compared with the other treatment method while maintaining good visual acuity. The primary objectives of this study are to compare visual acuity at 3 years following vitrectomy with endolaser or faricimab+PRP and to compare number of treatments for PDR (i.e., injections, PRP, vitrectomy) following the end of randomized treatment over 3 years.

研究类型

介入性

注册 (估计的)

426

阶段

  • 第三阶段

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。

学习联系方式

  • 姓名：Cynthia Stockdale
  • 电话号码：8139758690
  • 邮箱：drcrnet@jaeb.org

学习地点

  • 美国
    • California
      • Huntington Beach、California、美国、92647
        • 招聘中
        • Retina Associates of Southern California
        • 接触：
      • Loma Linda、California、美国、92354
        • 招聘中
        • Loma Linda University
        • 接触：
      • San Francisco、California、美国、94109
        • 招聘中
        • West Coast Retina Medical Group, Inc.
        • 接触：
      • Santa Barbara、California、美国、93103-4223
        • 招聘中
        • California Retina Consultants
        • 接触：
    • Florida
      • Jacksonville、Florida、美国、32209
        • 招聘中
        • University of Florida - Jacksonville
        • 接触：
      • Lakeland、Florida、美国、33805
        • 招聘中
        • Florida Retina Consultants
        • 接触：
      • Orlando、Florida、美国、32806
        • 招聘中
        • Ophthalmic Partners of Florida, PA dba Central Florida Retina
        • 接触：
      • Tampa、Florida、美国、33609
        • 招聘中
        • Retina Associates of Florida, LLC
        • 接触：
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 招聘中
        • Emory Eye Center
        • 接触：
          • Andrew M Hendrick, MD
          • 电话号码：404-778-4261
          • 邮箱：mafif@emory.edu
      • Augusta、Georgia、美国、30909
      • Sandy Springs、Georgia、美国、30328
        • 招聘中
        • Thomas Eye Group
        • 接触：
    • Illinois
      • Chicago、Illinois、美国、60612
        • 招聘中
        • Rush University Medical Center
        • 接触：
      • Oak Park、Illinois、美国、60304
        • 招聘中
        • Illinois Retina Associates SC Oak Park Site
        • 接触：
    • Indiana
      • Carmel、Indiana、美国、46032
        • 招聘中
        • Midwest Eye Institute
        • 接触：
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • The Trustees of Indiana University
        • 接触：
          • Amir R. Hajrasouliha, MD
          • 电话号码：317-944-2020
          • 邮箱：skarra@iu.edu
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • 招聘中
        • Wolfe Clinic, P.C.- West Des Moines
        • 接触：
    • Kansas
      • Overland、Kansas、美国、66211
        • 招聘中
        • Mid-America Retina Consultants, P.A.
        • 接触：
    • Kentucky
      • Lexington、Kentucky、美国、40508
        • 招聘中
        • University of Kentucky Advanced Eye Care
        • 接触：
    • Louisiana
      • West Monroe、Louisiana、美国、71291-4452
        • 招聘中
        • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
        • 接触：
    • Maryland
      • Baltimore、Maryland、美国、21237
        • 招聘中
        • Elman Retina Group, P.A.
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02215
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Boston Medical Center Corporation
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
        • 接触：
      • Saint Louis Park、Minnesota、美国、55416
        • 招聘中
        • Retina Consultants of Minnesota
        • 接触：
    • Missouri
      • St Louis、Missouri、美国、63128
        • 招聘中
        • Retina Research Institute, LLC
        • 接触：
    • New York
      • Rochester、New York、美国、14620
    • North Carolina
      • Chapel Hill、North Carolina、美国、27517-8923
        • 招聘中
        • University of North Carolina at Chapel Hill
        • 接触：
    • Oklahoma
      • Edmond、Oklahoma、美国、73013
        • 招聘中
        • Retina Vitreous Center
        • 接触：
    • Pennsylvania
      • Monroeville、Pennsylvania、美国、15146
    • Texas
      • Austin、Texas、美国、78705
      • Bellaire、Texas、美国、77401
      • Dallas、Texas、美国、75390
      • Houston、Texas、美国、77030-4101
        • 招聘中
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • 接触：
      • Lubbock、Texas、美国、79424
        • 招聘中
        • Texas Retina Associates
        • 接触：

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

18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:

Individual:

  • ≥ 18 years old
  • Diagnosis of diabetes mellitus (type 1 or type 2)

Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)

  • Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center
  • Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)

Exclusion Criteria:

  • Individual:

    • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.

    • Blood pressure > 160/100 (systolic above 160 or diastolic above 100).

      o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.

    • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.

      • Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.

Study Eye: (A participant can have two study eyes.)

  • Traction retinal detachment involving the macula
  • Significant vitreous hemorrhage that would preclude completion of a full PRP
  • Significant vitreomacular traction
  • Any prior vitrectomy
  • Any prior PRP (defined as ≥100 burns outside of the posterior pole)
  • Treatment for DME within the prior 6 months
  • Intravitreal anti-VEGF for any indication, other than DME, within the prior year

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：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：玻璃体切除术+内切激光
程序：Vitrectomy

The vitrectomy must occur within 4 weeks of randomization. A single injection of faricimab is allowed at any point before the vitrectomy. It is recommended that this injection is within 1 week of the vitrectomy. Requirement of triamcinolone staining to assist in complete elevation and removal of the posterior hyaloid and in removal of as much peripheral vitreous as is safely possible, 20 gauge not permitted. Allows subconjunctival steroid at investigator discretion; however, sub-tenon's triamcinolone or other long-acting steroid will not be permitted.

设备：Endolaser

Complete panretinal photocoagulation (PRP) during vitrectomy
实验性的：Faricimab + PRP

PRP = Panretinal Photocoagulation
药品：Faricimab

Treatment must be initiated on the day of randomization with one faricumab injection. The remainder of the randomized treatment includes 2 additional injections every 4-weeks. Injections must be completed within 90 days of randomization.

设备：Panretinal Photocoagulation (PRP)

Complete PRP. PRP may be completed in 1-3 sessions, with the timing at the investigator's discretion. All PRP sessions must be completed within 90 days of randomization.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visual Acuity Change from Baseline
大体时间：Baseline to 3- years

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40.
Baseline to 3- years
Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy
大体时间：Over 3 Years

Initial randomized treatment will be excluded.
Over 3 Years

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

Jaeb Center for Health Research

合作者

National Eye Institute (NEI)
Genentech, Inc.

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)

2025年8月4日

初级完成 (估计的)

2031年8月1日

研究完成 (估计的)

2031年8月1日

研究注册日期

首次提交

2025年1月10日

首先提交符合 QC 标准的

2025年1月23日

首次发布 (实际的)

2025年1月24日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2025年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Protocol AP
  • UG1EY014231 (美国 NIH 拨款/合同)

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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