A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME (BRUNELLO)
당뇨병성 황반부종이 있는 참가자를 대상으로 유리체강내 라니비주맙(0.5mg)과 유리체강내 라니비주맙(0.5mg)을 비교하여 유리체강내 EYE103의 효능과 안전성을 평가하기 위한 무작위, 이중 마스크, 다기관, 3-팔 중추 2/3상 연구
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
연구 개요
상세 설명
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose remigromig, high dose remigromig, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Frankfurt, 독일, 60590
- Frankfurt, Germany
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Hanover, 독일, 30625
- Hanover, Germany
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München, 독일, 80336
- Munchen, Germany
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Münster, 독일, 48145
- Munster, Germany
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Riga, 라트비아, LV1002
- Riga, Latvia
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Riga, 라트비아, LV1006
- Riga, Latvia
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Arizona
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Scottsdale, Arizona, 미국, 85255
- Scottsdale
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- Fayetteville, Arkansas
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Springdale, Arkansas, 미국, 72764
- Springdale, Arkansas
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California
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Bakersfield, California, 미국, 93309
- Bakersfield, CA
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Glendale, California, 미국, 91204
- Glendale, CA
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Modesto, California, 미국, 95356
- Modesto, CA
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Mountain View, California, 미국, 94040
- Mountain View, CA
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Redlands, California, 미국, 92374
- Redlands, CA
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Sacramento, California, 미국, 95825
- Sacramento, CA
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Sacramento, California, 미국, 95841
- Sacramento, CA
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Santa Ana, California, 미국, 92705
- Santa Ana
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Colorado
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Colorado Springs, Colorado, 미국, 80909
- Colorado Springs, CO
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Denver, Colorado, 미국, 80210
- Denver, Colorado
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Connecticut
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Danbury, Connecticut, 미국, 06810
- Danbury, CT
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Manchester, Connecticut, 미국, 06042
- Manchester, CT
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Waterford, Connecticut, 미국, 06385
- Waterford,CT
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Florida
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Deerfield Beach, Florida, 미국, 33064
- Deerfield Beach, FL
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Fort Lauderdale, Florida, 미국, 33308
- Fort Lauderdale, FL
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Fort Myers, Florida, 미국, 33912
- Fort Myers,FL
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Gainesville, Florida, 미국, 32607
- Gainesville, FL
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Orlando, Florida, 미국, 32806
- Orlando, Florida
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Plantation, Florida, 미국, 33324
- Plantation, FL
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Sarasota, Florida, 미국, 34232
- Sarasota, FL
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St. Petersburg, Florida, 미국, 33711
- Saint Petersburg, FL
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Tallahassee, Florida, 미국, 32308
- Tallahassee, FL
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Tampa, Florida, 미국, 33609-4614
- Tampa, FL
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Tampa, Florida, 미국, 33617
- Tampa, FL
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Winter Haven, Florida, 미국, 33880
- Winter Haven, FL
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Illinois
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Lemont, Illinois, 미국, 60439
- Lemont, IL
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Springfield, Illinois, 미국, 62702
- Springfield, Illinois
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Iowa
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West Des Moines, Iowa, 미국, 50266
- West Des Moines, IA
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Kansas
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Lenexa, Kansas, 미국, 66215
- Lenexa, Kansas
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Wichita, Kansas, 미국, 67214
- Wichita, Kansas
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Maine
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Portland, Maine, 미국, 04101
- Portland, Maine
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Maryland
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Hagerstown, Maryland, 미국, 21740
- Hagerstown, MD
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Massachusetts
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Springfield, Massachusetts, 미국, 01107
- Springfield,MA
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Michigan
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Grand Rapids, Michigan, 미국, 49546
- Grand Rapids, Michigan
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Minnesota
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Minneapolis, Minnesota, 미국, 55435
- Minneapolis, MN
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Mississippi
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Madison, Mississippi, 미국, 39110
- Madison, MS
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New Jersey
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Bloomfield, New Jersey, 미국, 07003
- Bloomfield, NJ
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Cherry Hill, New Jersey, 미국, 08034
- Cherry Hill, NJ
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New York
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Liverpool, New York, 미국, 13088
- Liverpool, NY
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Oceanside, New York, 미국, 11572
- Oceanside, NY
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Rochester, New York, 미국, 14620
- Rochester, NY
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North Carolina
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Asheville, North Carolina, 미국, 28803
- Asheville, NC
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Hickory, North Carolina, 미국, 28602
- Hickory, NC
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Wake Forest, North Carolina, 미국, 27587
- Wake Forest, MC
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Winston-Salem, North Carolina, 미국, 27103
- Winston Salem, NC
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Ohio
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Cleveland, Ohio, 미국, 44122
- Cleveland, Ohio
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Cleveland, Ohio, 미국, 44130
- Cleveland, OH
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Youngstown, Ohio, 미국, 44505
- Youngstown, Ohio
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Oklahoma
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Edmond, Oklahoma, 미국, 73013
- Edmond, OK
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Oregon
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Portland, Oregon, 미국, 97221
- Portland, OR
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Springfield, Oregon, 미국, 97477
- Springfield, Oregon
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Pennsylvania
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Bethlehem, Pennsylvania, 미국, 18017
- Bethlehem, PA
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Erie, Pennsylvania, 미국, 16507
- Erie, PA
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South Carolina
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Beaufort, South Carolina, 미국, 29902
- Beaufort, SC
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Florence, South Carolina, 미국, 29501
- Florence, SC
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Ladson, South Carolina, 미국, 29456
- Ladson, SC
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West Columbia, South Carolina, 미국, 29169
- West Columbia, SC
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Tennessee
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Germantown, Tennessee, 미국, 38138
- Germantown, TN
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Hixson, Tennessee, 미국, 37343
- Hixson, Tennessee
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Johnson City, Tennessee, 미국, 37604
- Johnson City, Tennessee
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Knoxville, Tennessee, 미국, 37922
- Knoxville, TN
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Nashville, Tennessee, 미국, 37203
- Nashville, TN
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Texas
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Abilene, Texas, 미국, 79606
- Abilene, TX
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Amarillo, Texas, 미국, 79109
- Amarillo, TX
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Amarillo, Texas, 미국, 79106
- Amarillo, TX
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Arlington, Texas, 미국, 76012
- Arlington, TX
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Austin, Texas, 미국, 78705
- Austin, TX
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Beaumont, Texas, 미국, 77707
- Beaumont, TX
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Bellaire, Texas, 미국, 77401
- Bellaire, TX
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Dallas, Texas, 미국, 75231
- Dallas, TX
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Fort Worth, Texas, 미국, 76104
- Fort Worth, TX
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Katy, Texas, 미국, 77494
- Katy, TX
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Plano, Texas, 미국, 75075
- Plano, TX
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Round Rock, Texas, 미국, 78681
- Round Rock, TX
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San Antonio, Texas, 미국, 78240
- San Antonio, TX
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Schertz, Texas, 미국, 78154
- Schertz, Texas
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The Woodlands, Texas, 미국, 77384
- The Woodlands, TX
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Willow Park, Texas, 미국, 76087
- Willow Park, TX
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Utah
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Salt Lake City, Utah, 미국, 84107
- Salt Lake City, Utah
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Virginia
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Lynchburg, Virginia, 미국, 24502
- Lynchburg, VA
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Richmond, Virginia, 미국, 23235
- Richmond, Virginia
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Washington
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Spokane, Washington, 미국, 99204
- Spokane, WA
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Barcelona, 스페인, 08035
- Barcelona, Spain
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Barcelona, 스페인, 08021
- Barcelona, Spain
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Barcelona, 스페인, 08022
- Barcelona, Spain
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Barcelona, 스페인, 08195
- Barcelona, Spain
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Santiago de Compostela, 스페인, 15706
- Santiago de Compostela, Spain
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Seville, 스페인, 41009
- Sevilla, Spain
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Zaragoza, 스페인, 50009
- Zaragoza, Spain
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Valencia
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Burjassot, Valencia, 스페인, 46100
- Valencia, Spain
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Trebišov, 슬로바키아, 075 01
- Trebisov, Slovakia
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Trenčín, 슬로바키아, 911 01
- Trencin, Slovakia
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Žilina, 슬로바키아, 012 07
- Zilina, Slovakia
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CABA, 아르헨티나, 1023
- Buenos Aires, Argentina
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Córdoba, 아르헨티나, X5000AAJ
- Ciudad de Cordoba, Argentina
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Buenos Aires
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CABA, Buenos Aires, 아르헨티나, 1015
- Buenos Aires, Argentina
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CABA, Buenos Aires, 아르헨티나, 1120
- Buenos Aires, Argentina
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CABA, Buenos Aires, 아르헨티나, C1033AAW
- Buenos Aires, Argentina
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Caba, Buenos Aires, 아르헨티나, C1116ABA
- Caba, Buenos Aires, Argentina
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Córdoba Province
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Córdoba, Córdoba Province, 아르헨티나, 5000
- Cordoba, Argentina
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Santa Fe Province
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Rosario, Santa Fe Province, 아르헨티나, S2000DSK
- Santa Fe, Argentina
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Sante Fe
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Rosario, Sante Fe, 아르헨티나, 2000
- Santa Fe, Argentina
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Bradford, 영국, BD9 6RJ
- Bradford, United Kingdom
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Bristol, 영국, BS1 2LX
- Bristol, UK
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Liverpool, 영국, L7 8YA
- Liverpool, United Kingdom
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Sunderland, 영국, SR2 9HP
- Sunderland, United Kingdom
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Wolverhampton, 영국, WV10 0QP
- Wolverhamptom, United Kingdom
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Middlesex
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London, Middlesex, 영국, NW10 7NS
- London, UK
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UnitedKingdom
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York, UnitedKingdom, 영국, YO10 4DZ
- York, United Kingdom
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Graz, 오스트리아, 8036
- Graz, Austria
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Innsbruck, 오스트리아, 6020
- Innsbruck, Austria
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Vienna, 오스트리아, 1090
- Vienna, Austria
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Vienna, 오스트리아, 1140
- Vienna, Austria
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Be’er Ya‘aqov, 이스라엘, 70300
- Beer Yakov, Israel
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Haifa, 이스라엘, 3436212
- Haifa, Israel
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Jerusalem, 이스라엘, 9112001
- Jerusalem, Israel
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Petah Tikva, 이스라엘, 49100
- Petah Tikva, Israel
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Rehovot, 이스라엘, 76100
- Rehovot, Israel
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Tel Aviv, 이스라엘, 6423906
- Tel Aviv, Israel
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Bologna, 이탈리아, 40138
- Bologna, Italy
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Florence, 이탈리아, 50139
- Firenze, Italy
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Milan, 이탈리아, 20122
- Milano, Italy
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Milan, 이탈리아, 20132
- Milano, Italy
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Milan, 이탈리아, 20157
- Milano, Italy
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Roma, 이탈리아, 00168
- Roma, Italy
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Rome, 이탈리아, 81.00133
- Rome, Italy
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Udine, 이탈리아, 33100
- Udine, Italy
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Mladá Boleslav, 체코, 293 01
- Mlada Boleslav, Czechia
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Náchod, 체코, 547 01
- Nachod, Czechia
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Prague, 체코, 1150/50
- Prague, Czechia
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Prague, 체코
- Prague, Czechia
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Medellín, 콜롬비아, 50016
- Medellin, Colombia
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Antioquia
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Medellín, Antioquia, 콜롬비아, 50021
- Medellin, Colombia
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Atlántico
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Barranquilla, Atlántico, 콜롬비아, 80002
- Barranquilla, Colombia
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Columbia
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Bogotá, Columbia, 콜롬비아, 110231
- Bogota, Columbia
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Valle del Cauca Department
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Cali, Valle del Cauca Department, 콜롬비아, 760042
- Cali, Colombia
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Osijek, 크로아티아, 31000
- Osijek, Croatia
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Turkey
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Ankara, Turkey, 터키 (Türkiye), 06230
- Ankara, Turkey
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Ankara, Turkey, 터키 (Türkiye), 06490
- Ankara, Turkey
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Balçova, Turkey, 터키 (Türkiye), 35330
- Balcova, Turkey
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Coimbra, 포르투갈, 3000-548
- Coimbra, Portugal
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Coimbra, 포르투갈, 3030-163
- Coimbra, Portugal
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Porto, 포르투갈, 4200-319
- Porto, Portugal
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Bialystok, 폴란드, 15-866
- Bialystok, Poland
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Bydgoszcz, 폴란드, 85-309
- Bydgoszcz, Poland
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Bydgoszcz, 폴란드, 85-631
- Bydgoszcz, Poland
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Gdansk, 폴란드, 80-809
- Gdansk, Poland
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Katowice, 폴란드, 40-594
- Katowice, Poland
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Krakow, 폴란드, 31-501
- Krakow, Poland
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Olsztyn, 폴란드, 10-424
- Olsztyn, Poland
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Tarnowskie Góry, 폴란드, 42-600
- Tarnowskie Gory, Poland
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Gdansk
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Gdansk, Gdansk, 폴란드, 80-809
- Gdansk, Poland
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PR
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Arecibo, PR, 푸에르토 리코, 00612
- Arecibo, PR
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Créteil, 프랑스, 94010
- Creteil, France
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Lyon, 프랑스, 69004
- Lyon, France
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Marseille, 프랑스, 13008
- Marseille, France
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Paris, 프랑스, 75006
- Paris, France
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Paris, 프랑스, 75015
- Paris, France
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Paris, 프랑스, 75019
- Paris, France
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Saint-Cyr-sur-Loire, 프랑스, 37540
- Saint Cyr sur Loire, France
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Cedex
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Dijon, Cedex, 프랑스, 21079
- Cedex, France
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Budapest, 헝가리, H-1062
- Budapest, Hungary
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Budapest, 헝가리, H-1085
- Budapest, Hungary
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Budapest, 헝가리, H-1106
- Budapest, Hungary
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Budapest, 헝가리, H-1133
- Budapest, Hungry
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Debrecen, 헝가리, H-4032
- Debrecen, Hungary
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Pécs, 헝가리, H-7621
- Pecs, Hungary
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Szeged, 헝가리, H-6720
- Szeged, Hungary
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Zalaegerszeg, 헝가리, 8900
- Zalaegerszeg, Hungary
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Albury, 호주, 2640
- Albury, Australia
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Parramatta, 호주, 2150
- Parramatta, Australia
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Sydney, 호주, 2000
- Sydney, Australia
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New South Wales
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Sydney, New South Wales, 호주, 2000
- Sydney Retina Clinic
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Sydney, New South Wales, 호주, 2135
- Sydney, Australia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- Be male or female ≥18 years of age.
- Have type 1 or type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%.
- Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME).
Exclusion Criteria:
-
Be pregnant or breastfeeding
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History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
-
Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
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Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
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If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
- Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
- Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Remigromig Low Dose Treatment Arm
Remigromig Low Dose Treatment Arm |
Remigromig is a humanized antibody formulated for intravitreal administration
다른 이름들:
|
|
실험적: Remigromig High Dose Treatment Arm
Remigromig High Dose Treatment Arm |
Remigromig is a humanized antibody formulated for intravitreal administration
다른 이름들:
|
|
활성 비교기: Ranibizumab Treatment Arm
Ranibizumab Treatment Arm |
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
기간: Baseline and Week 52
|
The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented. |
Baseline and Week 52
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52
기간: Baseline and Week 52
|
The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented. |
Baseline and Week 52
|
|
Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52
기간: Baseline and Week 52
|
The Superiority Hypothesis: change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented. |
Baseline and Week 52
|
|
Time to Absence of Diabetic Macular Edema (DME)
기간: Up to approximately Week 104
|
The time to absence of Diabetic Macular Edema (DME) defined as Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) of <300 μm will be presented. |
Up to approximately Week 104
|
|
Time to Gaining ≥15 ETDRS letters
기간: Up to approximately Week 52
|
The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented. |
Up to approximately Week 52
|
|
Proportion of Participants with Resolution of Macular Leakage on FA at Week 24
기간: Up to approximately Week 24
|
The proportion of participants with resolution of macular leakage on fluorescein angiography (FA), defined as 0 to 1 mm^2, at Week 24 will be presented. |
Up to approximately Week 24
|
|
Proportion of Participants Without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52
기간: Up to approximately Week 52
|
The proportion of participants without intraretinal and subretinal fluid at the foveal center on Optical Coherence Tomography (OCT) at Week 52 will be presented. |
Up to approximately Week 52
|
|
Change from Baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52
기간: Baseline and Week 52
|
The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented. |
Baseline and Week 52
|
|
Proportion of Participants Achieving 20/40 or Better BCVA at Week 52
기간: Up to approximately Week 52
|
The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented. |
Up to approximately Week 52
|
|
Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)
기간: Up to approximately 104 Weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic AE will be reported. |
Up to approximately 104 Weeks
|
|
Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)
기간: Up to approximately 104 Weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic serious adverse event (SAE) will be reported. |
Up to approximately 104 Weeks
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 104 Weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 104 Weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Charles Miller, MD PhD, EyeBiotech Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- EYE-RES-102
- MK-3000-001 (기타 식별자: MSD)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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