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당뇨병성 황반부종에서 RO7200220에 대한 연구

2026년 4월 17일 업데이트: Hoffmann-La Roche

당뇨병성 황반부종 환자에서 유리체강내로 투여된 RO7200220의 효능, 안전성, 내약성, 약동학 및 약력학을 조사하기 위한 제2상, 다기관, 무작위, 이중 마스킹, 활성 비교 대조 연구

연구 BP43445는 당뇨병성 황반 부종이 있는 참가자에게 유리체강내로 투여된 RO7200220의 효능, 안전성, 내약성, 약동학 및 약력학을 조사하기 위한 제2상, 다기관, 무작위, 이중 차폐, 활성 비교 대조 연구입니다. 한쪽 눈만 연구 눈으로 선택됩니다. 연구 기간은 최대 76주입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

394

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Daegu, 대한민국, 42415
        • Yeungnam University Medical Center
      • Seongnam-si, 대한민국, 13605
        • Seoul National University Bundang Hospital
      • Seoul, 대한민국, 05505
        • Asan Medical Center
      • Seoul, 대한민국, 06351
        • Samsung Medical Center
      • Seoul, 대한민국, 07301
        • Kim's Eye Hospital
  • 미국
    • California
      • Arcadia, California, 미국, 91006
        • Win Retina
      • Poway, California, 미국, 92064
        • Retina Consultants, San Diego
      • Sacramento, California, 미국, 95825
        • Retinal Consultants Med Group
      • Walnut Creek, California, 미국, 94598
        • Bay Area Retina Associates
    • Colorado
      • Lakewood, Colorado, 미국, 80228
        • Colorado Retina Associates, PC
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20011-3010
        • Emerson Clinical Research Institute LLC
    • Florida
      • Deerfield Beach, Florida, 미국, 33064
        • Rand Eye
      • Fort Myers, Florida, 미국, 33912
        • National Ophthalmic Research Institute
      • Orlando, Florida, 미국, 32806-1101
        • Florida Retina Institute
      • St. Petersburg, Florida, 미국, 33607
        • Retina Vitreous Associates of Florida
      • Wesley Chapel, Florida, 미국, 33544
        • Retina Specialists of Tampa
    • Kentucky
      • Louisville, Kentucky, 미국, 40206
        • Butchertown Clinical Trials
    • Maryland
      • Hagerstown, Maryland, 미국, 21740
        • Cumberland Valley Retina PC
    • Mississippi
      • Southaven, Mississippi, 미국, 38671
        • Deep Blue Retina PLLC
    • Nevada
      • Reno, Nevada, 미국, 89502
        • Sierra Eye Associates
    • New York
      • Lynbrook, New York, 미국, 11563
        • Opthalmic Consultants of LI
      • Rochester, New York, 미국, 14642
        • University of Rochester Flaum Eye Institute
    • North Carolina
      • Asheville, North Carolina, 미국, 28803
        • Western Carolina Retinal Associate PA
      • Winston-Salem, North Carolina, 미국, 27157
        • Wake Forest Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, 미국, 45219
        • Meridian Clinical Research
    • Oregon
      • Eugene, Oregon, 미국, 97401
        • Verum Research LLC
      • Portland, Oregon, 미국, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, 미국, 16507
        • Erie Retinal Surgery
      • Kingston, Pennsylvania, 미국, 18704
        • Eye Care Specialists, PC
      • Sewickley, Pennsylvania, 미국, 15143
        • Sewickley Eye Group
    • South Carolina
      • Ladson, South Carolina, 미국, 29456
        • Charleston Neuroscience Institute
    • South Dakota
      • Rapid City, South Dakota, 미국, 57701
        • Black Hills Eye Institute
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • Retina Consultants of Nashville
    • Texas
      • Arlington, Texas, 미국, 75075
        • Texas Retina Associates
      • Austin, Texas, 미국, 78750
        • Austin Clinical Research LLC
      • Bellaire, Texas, 미국, 77401
        • Retina Consultants of Texas
      • McAllen, Texas, 미국, 78503
        • Valley Retina Institute P.A.
      • The Woodlands, Texas, 미국, 78240
        • Retina Consultants of Texas
      • Willow Park, Texas, 미국, 76087
        • Strategic Clinical Research Group, LLC
    • Virginia
      • Lynchburg, Virginia, 미국, 24502
        • Piedmont Eye Center
      • Norfolk, Virginia, 미국, 23502
        • Wagner Macula & Retina Center
  • 스페인
      • Zaragoza, 스페인, 50009
        • Hospital Universitario Miguel Servet
    • Barcelona
      • Sant Cugat de Valles, Barcelona, 스페인, 08190
        • Hospital General De Catalunya
    • Madrid
      • Majadahonda, Madrid, 스페인, 28222
        • Hospital Universitario Puerta De Hierro
    • Valencia
      • Burjassot, Valencia, 스페인, 46100
        • Oftalvist Valencia
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1015ABO
        • Organizacion Medica de Investigacion
      • Capital Federal, 아르헨티나, C1120AAN
        • Oftalmos
      • Capital Federal, 아르헨티나, C1116
        • Centro Oftalmologico Dr. Charles S.A.
      • Ciudad Autonoma Buenos Aires, 아르헨티나, C1061AAE
        • Buenos Aires Mácula
      • Córdoba, 아르헨티나
        • Centro Privado de Ojos Romagosa
      • Lomas de Zamora, 아르헨티나
        • Centro de ojos Loria
      • Mendoza, 아르헨티나, M5500GGK
        • OFTAR
      • Rosario, 아르헨티나, S2000CTC
        • Microcirugía Ocular S.A
      • Rosario, 아르헨티나, S2000DLA
        • Grupo Laser Vision
  • 영국
      • Bristol, 영국, BS1 2LX
        • Bristol Eye Hospital
      • Gloucestershire, 영국, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
      • Guildford, 영국, GU2 7XX
        • Royal Surrey County Hospital
      • London, 영국, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Newcastle upon Tyne, 영국, NE1 4LP
        • Royal Victoria Infirmary
  • 체코
      • Ostrava, 체코, 708 52
        • Faculty Hospital Ostrava
      • Prague, 체코
        • AXON clinical
      • Prague, 체코, 128 08
        • General Teaching Hospital Prague
      • Prague, 체코, 100 34
        • Faculty Hospital Kralovske Vinohrady
  • 캐나다
    • Ontario
      • Ottawa, Ontario, 캐나다, K2B 7E9
        • Retina Institute of Ottawa
      • Toronto, Ontario, 캐나다, M3C 0G9
        • Toronto Retina Institute
    • Quebec
      • Boisbriand, Quebec, 캐나다, J7H 0E8
        • Institut De L'Oeil Des Laurentides
  • 폴란드
      • Gliwice, 폴란드, 44-100
        • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
      • Katowice, 폴란드, 40-514
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, 폴란드, 31-070
        • Centrum Medyczne UNO-MED
      • Lublin, 폴란드, 20-079
        • SPSK nr 1 w Lublinie
      • Olsztyn, 폴란드, 10-424
        • Centrum Diagnostyki i Mikrochirurgii Oka LENS
      • Rybnik, 폴란드, 44-203
        • LensClinic
      • Tarnowskie Góry, 폴란드, 42-600
        • Caminomed
  • 푸에르토 리코
      • Arecibo, 푸에르토 리코, 00612
        • Emanuelli Research and Development Center LLC

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 당뇨병 진단(제1형 또는 제2형)
  • 황반 중심을 포함하는 당뇨병성 황반부종(DME)에 이차적인 황반 비후
  • 주로 DME에 기인한 시력 감소
  • 서면 동의서를 제공하고 연구 프로토콜을 준수할 수 있는 능력 및 의지
  • 수액 수집 허용 의향
  • 가임기 여성의 경우: 금욕을 유지하거나 최소 1가지 이상의 매우 효과적인 피임법을 사용하여 실패율이

제외 기준:

  • 헤모글로빈 A1c(HbA1c) 12% 초과(>)
  • 환자가 휴식을 취하는 동안 수축기 수치가 180mmHg(수은주)보다 크거나(>) 이완기 수치가 100mmHg 이상인 조절되지 않는 혈압
  • 현재 임신 ​​중이거나 모유 수유 중이거나 연구 기간 동안 임신할 계획이 있는 사람
  • 연구 눈에 대한 범망막 광응고술 또는 황반 레이저로 사전 치료
  • 연구 안구에 대한 1일 전 지난 16주 이내에 임의의 안구내 또는 안구주위 코르티코스테로이드 치료
  • 연구 안구에 대한 1일 전 3년 이내의 이전 Iluvien 또는 Retisert 임플란트
  • 연구 안구에 대한 1일 전 8주 이내에 항-VEGF 요법으로 이전 또는 동시 치료; 1일 전 16주 이내의 Vabysmo^TM, 이전 Beovu®는 허용되지 않습니다.
  • IVT 브롤루시주맙(Beovu®)의 사전 투여: 항상; RO7200220:
  • 모든 증식성 당뇨병성 망막병증
  • 연구 눈의 활동성 안구내 또는 안구주위 감염 또는 활동성 안구내 염증
  • 황반의 평가를 혼란스럽게 하거나 연구 안구의 중심 시력에 영향을 미칠 수 있는 DME 이외의 안구 질환의 현재 또는 과거력
  • 연구자의 의견에 따라 연구 안구에서 DME 이외의 원인으로 인해 현재 돌이킬 수 없는 시력 손실을 유발하거나 기여할 것으로 예상되는 모든 현재 안구 상태
  • 다른 프로토콜 지정 포함/제외 기준이 적용될 수 있습니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 아암 D: 라니비주맙 Q4W 0.5mg
참가자는 1일차와 4주차에 최대 44주까지 총 12회 IVT 주사로 라니비주맙 0.5mg을 투여받게 됩니다.
의약품: 라니비주맙
Ranibizumab 0.5mg은 치료군에 명시된 대로 IVT 주사로 참가자에게 투여됩니다.
다른 이름들:
  • 루센티스
실험적: 팔 A: 0.25mg 바미키바트 Q8W
참가자는 1일차와 8주마다(Q8W) 최대 44주차까지 총 6회 유리체강내(IVT) 주사를 통해 바미키바트 0.25밀리그램(mg)을 투여받게 됩니다. 치료군 사이의 마스킹을 유지하기 위해 연구 약물이 투여되지 않는 연구 방문 동안 가짜 절차가 시행될 것입니다.
다른: 가짜 절차
Sham은 IVT 주사를 모방하는 절차로, 빈 주사기(바늘 없음)의 뭉툭한 끝을 마취된 눈에 대고 누르는 절차입니다. 치료 암 사이에 마스킹을 유지하기 위해 적용 가능한 방문 시 Q8W 암의 참가자에게 가짜 절차가 시행됩니다.
의약품: 바미키바트
Vamikibart는 각 치료군에 명시된 대로 IVT 주사로 투여됩니다.
다른 이름들:
  • RO7200220
실험적: 팔 B: 1.0mg 바미키바트 Q8W
참가자는 1일차와 Q8W에 최대 44주차까지 총 6회 주사로 바미키바트 1.0mg을 IVT 주사로 투여받게 됩니다. 치료군 사이의 마스킹을 유지하기 위해 연구 약물이 투여되지 않는 연구 방문 동안 가짜 절차가 시행될 것입니다.
다른: 가짜 절차
Sham은 IVT 주사를 모방하는 절차로, 빈 주사기(바늘 없음)의 뭉툭한 끝을 마취된 눈에 대고 누르는 절차입니다. 치료 암 사이에 마스킹을 유지하기 위해 적용 가능한 방문 시 Q8W 암의 참가자에게 가짜 절차가 시행됩니다.
의약품: 바미키바트
Vamikibart는 각 치료군에 명시된 대로 IVT 주사로 투여됩니다.
다른 이름들:
  • RO7200220
실험적: 암 C: 1.0mg 바미키바트 Q4W
참가자는 1일차와 4주마다(Q4W), 최대 44주차까지 총 12회 주사로 바미키바트 1.0mg을 IVT 주사로 투여받게 됩니다.
의약품: 바미키바트
Vamikibart는 각 치료군에 명시된 대로 IVT 주사로 투여됩니다.
다른 이름들:
  • RO7200220

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
기간: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Systemic and Ocular Adverse Events (AEs)
기간: Up to Week 72
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye.
Up to Week 72
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
기간: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
기간: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
기간: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
기간: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
기간: Baseline, Weeks 32 and 36
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
기간: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
기간: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
기간: Baseline, Weeks 20 and 24
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
기간: From baseline up to Week 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
From baseline up to Week 72
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
기간: From baseline up to Week 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
From baseline up to Week 72
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants
기간: Baseline, Weeks 44 and 48
CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants
기간: Baseline, Weeks 44 and 48
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population
기간: Baseline, Weeks 44 and 48
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants
기간: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants
기간: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population
기간: Baseline, Weeks 32 and 36
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants
기간: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants
기간: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population
기간: Baseline, Weeks 20 and 24
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 20 and 24
Change From Baseline in CST Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Absence of DME was defined as CST < 325 µm for spectralis SD-OCT, or < 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized.
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
기간: Baseline, Weeks 4, 12, 24, 36, 48, and 72
The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with the absence of IRF at the foveal center were reported. Percentages have been summarized.
Baseline, Weeks 4, 12, 24, 36, 48, and 72
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
기간: Baseline, Weeks 4, 12, 24, 36, 48, and 72
The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized.
Baseline, Weeks 4, 12, 24, 36, 48, and 72

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

수사관

  • 연구 책임자: Clinical Trials, Hoffmann-La Roche

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 12월 31일

기본 완료 (실제)

2024년 11월 6일

연구 완료 (실제)

2025년 4월 21일

연구 등록 날짜

최초 제출

2021년 12월 8일

QC 기준을 충족하는 최초 제출

2021년 12월 8일

처음 게시됨 (실제)

2021년 12월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 17일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BP43445
  • 2021-003756-16 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

자격을 갖춘 연구원은 임상 연구 데이터 요청 플랫폼(www.vivli.org/)을 통해 개별 환자 수준 데이터에 대한 액세스를 요청할 수 있습니다. 적격 연구에 대한 Roche의 기준에 대한 자세한 내용은 여기(https://vivli.org/ourmember/roche/)에서 확인할 수 있습니다.

임상 정보 공유에 관한 Roche의 글로벌 정책 및 관련 임상 연구 문서에 대한 액세스 요청 방법에 대한 자세한 내용은 여기(https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)를 참조하십시오.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다