A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Last updated: June 24, 2026
Sponsor: EyeBiotech Ltd.
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Macular Edema

Treatment

Ranibizumab

EYE103

Clinical Study ID

NCT06957080
EYE-RES-103
  • Ages > 18
  • All Genders

Study Summary

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of 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 EYE103 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Be willing and able to understand the study procedures and the risks involved andprovide 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 beprimarily the result of diabetic macular edema (DME).

Exclusion

Exclusion Criteria:

  • Be pregnant or breastfeeding

  • History of cataract surgery and/or minimally invasive glaucoma surgery in the studyeye within 90 days of Screening

  • Have any treatment for complications of cataract surgery with steroids or yttriumaluminum garnet (YAG) laser capsulotomy within 90 days of Screening

  • Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine,pentosan polysulfate sodium, and amiodarone)

  • If treatment-experienced for DME have a history of any of the following treatmentswithin the noted time windows:

  • Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) orfaricimab (VABYSMO) within 120 days prior to the Screening visit

  • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab,aflibercept [2 mg], pegaptanib sodium) in the study eye within 90 days of theScreening visit

Study Design

Total Participants: 1054
Treatment Group(s): 2
Primary Treatment: Ranibizumab
Phase: 2/3
Study Start date:
April 16, 2025
Estimated Completion Date:
March 30, 2028

Study Description

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 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 EYE103, high dose EYE103, 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 EYE103 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.

Connect with a study center

  • Buenos Aires, Argentina

    Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • Buenos Aires, Argentina

    Buenos Aires 3435910, B1878KDF
    Argentina

    Site Not Available

  • Cordoba, Argentina

    Córdoba, X5000
    Argentina

    Site Not Available

  • Cordoba, Argentina

    Córdoba 3860259, X5000
    Argentina

    Site Not Available

  • Salta, Argentina

    Salta, A4400
    Argentina

    Site Not Available

  • Salta, Argentina

    Salta 3838233, 4400
    Argentina

    Site Not Available

  • Santa Fe, Argentina

    Santa Fe, S2000
    Argentina

    Site Not Available

  • Aparecida De Goiania, Brazil

    Aparecida de Goiânia, 74210-010
    Brazil

    Site Not Available

  • Aparecida de Goiania, Brazil

    Aparecida de Goiânia, 74980-010
    Brazil

    Site Not Available

  • Aparecida De Goiania, Brazil

    Aparecida de Goiânia 6316406, 74210-010
    Brazil

    Site Not Available

  • Assis, Brazil

    Assis, 19814-470
    Brazil

    Site Not Available

  • Belo Horizonte, Brazil

    Belo Horizonte, 30330-000
    Brazil

    Site Not Available

  • Blumenau, Brazil

    Blumenau, 89010-204
    Brazil

    Site Not Available

  • Porto Alegre, Brazil

    Porto Alegre, 90.440-051
    Brazil

    Site Not Available

  • Sorocaba, Brazil

    Sorocaba, 18031-060
    Brazil

    Site Not Available

  • Sao Paulo, Brazil

    São Paulo, 04023-062
    Brazil

    Site Not Available

  • Sao Paulo, Brazil

    São Paulo 3448439, 04023-062
    Brazil

    Site Not Available

  • Vitoria, Brazil

    Vitória, 29055-450
    Brazil

    Site Not Available

  • Barranquilla, Colombia

    Barranquilla, 080001
    Colombia

    Site Not Available

  • Bogata, Colombia

    Bogotá, 110231
    Colombia

    Site Not Available

  • Cali, Colombia

    Cali, 760042
    Colombia

    Site Not Available

  • Medelin, Colombia

    Medellín, 050021
    Colombia

    Site Not Available

  • Medellin, Colombia

    Medellín, 50021
    Colombia

    Site Not Available

  • Medellin, Colombia

    Medellín 3674962, 50021
    Colombia

    Site Not Available

  • Nagoya City, Japan

    Nagoya, Aichi-ken 466-8560
    Japan

    Site Not Available

  • Hirosaki, Japan

    Hirosaki, Aomori 036-8563
    Japan

    Site Not Available

  • Sakura, Japan

    Sakura, Chiba 285-8741
    Japan

    Site Not Available

  • Yoshida-gun, Japan

    Yoshida-gun, Fukui 910-1193
    Japan

    Site Not Available

  • Fukuoka-shi, Japan

    Fukuoka, Fukuoka 812-0011
    Japan

    Site Not Available

  • Kurume City, Japan

    Kurume, Fukuoka 830-8543
    Japan

    Site Not Available

  • Fukuoka-shi, Japan

    Fukuoka 1863967, Fukuoka 1863958 812-0011
    Japan

    Site Not Available

  • Asahikawa, Japan

    Asahikawa, Hokkaido 078-8510
    Japan

    Site Not Available

  • Amagasaki, Japan

    Amagasaki, Hyōgo 660-8550
    Japan

    Site Not Available

  • Mito, Japan

    Mito, Ibaraki 310-0845
    Japan

    Site Not Available

  • Kita-gun, Japan

    Kita-gun, Kagawa-ken 761-0793
    Japan

    Site Not Available

  • Kagoshima City, Japan

    Kagoshima, Kagoshima-ken 890-8520
    Japan

    Site Not Available

  • Tokorozawa-shi, Japan

    Tokorozawa-shi, Saitama 359-8513
    Japan

    Site Not Available

  • Shimotsuke-shi, Japan

    Shimotsuke-shi, Tochigi 329-0498
    Japan

    Site Not Available

  • Hachioji, Japan

    Hachiōji, Tokyo 193-0998
    Japan

    Site Not Available

  • Meguro-ku, Japan

    Meguro-ku, Tokyo 152-8902
    Japan

    Site Not Available

  • Taito-ku, Japan

    Taito-ku, Tokyo 111-0051
    Japan

    Site Not Available

  • Ube-shi, Japan

    Ube-shi, Yamaguchi 755-8505
    Japan

    Site Not Available

  • Fukushima, Japan

    Fukushima, 960-1295
    Japan

    Site Not Available

  • Miyazaki, Japan

    Miyazaki, 889-1692
    Japan

    Site Not Available

  • Osaka, Japan

    Osaka, 545-8586
    Japan

    Site Not Available

  • Osaka, Japan

    Osaka 1853909, 530-8480
    Japan

    Site Not Available

  • Tokushima, Japan

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Tokyo, Japan

    Tokyo, 101-8309
    Japan

    Site Not Available

  • Yamagata, Japan

    Yamagata, 990-9585
    Japan

    Site Not Available

  • Arecibo, PR

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • San Juan, Puerto Rico

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Gilbert, Arizona

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Phoenix, Arizona

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Scottsdale, AZ

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Fayetteville, AR

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Bakersfield, CA

    Bakersfield, California 93309
    United States

    Site Not Available

  • Encino, California

    Encino, California 91436
    United States

    Site Not Available

  • Modesto, CA

    Modesto, California 95356
    United States

    Site Not Available

  • Mountain View, CA

    Mountain View, California 94040
    United States

    Site Not Available

  • Redlands, CA

    Redlands, California 92374
    United States

    Site Not Available

  • Sacramento, CA

    Sacramento, California 95825
    United States

    Site Not Available

  • Santa Ana

    Santa Ana, California 92705
    United States

    Site Not Available

  • Santa Ana, CA

    Santa Ana, California 92705
    United States

    Site Not Available

  • Sacramento, CA

    Sacramento 5389489, California 5332921 95825
    United States

    Site Not Available

  • Santa Ana, CA

    Santa Ana 5392900, California 5332921 92705
    United States

    Site Not Available

  • Colorado Springs, CO

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Denver, CO

    Denver, Colorado 80012
    United States

    Site Not Available

  • Durango, CO

    Durango, Colorado 81303
    United States

    Site Not Available

  • Danbury, CT

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Manchester, CT

    Manchester, Connecticut 06042
    United States

    Site Not Available

  • Waterford, CT

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Waterford,CT

    Waterford, Connecticut 06385
    United States

    Site Not Available

  • Waterford,CT

    Waterford 8480031, Connecticut 4831725 06385
    United States

    Site Not Available

  • Deerfield Beach, FL

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Fort Lauderdale, FL

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Fort Myers, FL

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Gainesville, FL

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Orlando, FL

    Orlando, Florida 32806
    United States

    Site Not Available

  • Plantation, FL

    Plantation, Florida 33324
    United States

    Site Not Available

  • Sarasota, FL

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Saint Petersburg, FL

    St. Petersburg, Florida 33711
    United States

    Site Not Available

  • Tallahassee, FL

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Tampa, FL

    Tampa, Florida 33609
    United States

    Site Not Available

  • Winter Haven, FL

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Tampa, FL

    Tampa 4174757, Florida 4155751 33617
    United States

    Site Not Available

  • Joliet, Illinois

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Lemont, IL

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Oak Park, IL

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • Springfield, IL

    Springfield, Illinois 62702
    United States

    Site Not Available

  • West Des Moines, IA

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Lenexa, KS

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Wichita, Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Portland, ME

    Portland, Maine 04101
    United States

    Site Not Available

  • Baltimore, Maryland

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Hagerstown, MD

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Towson, MD

    Towson, Maryland 21204
    United States

    Site Not Available

  • Springfield,MA

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Grand Rapids, MI

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Edina, MN

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Minneapolis, MN

    Minneapolis, Minnesota 55435
    United States

    Site Not Available

  • Madison, MS

    Madison, Mississippi 39110
    United States

    Site Not Available

  • Henderson, Nevada

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Bloomfield, NJ

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Cherry Hill, NJ

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Albuquerque, New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Great Neck, New York

    Great Neck, New York 11021
    United States

    Site Not Available

  • Hauppauge, New York

    Hauppauge, New York 11788
    United States

    Site Not Available

  • Liverpool, NY

    Liverpool, New York 13088
    United States

    Site Not Available

  • New York, NY

    New York, New York 10022
    United States

    Site Not Available

  • Rochester, NY

    Rochester, New York 14620
    United States

    Site Not Available

  • Asheville, NC

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Cary, North Carolina

    Cary, North Carolina 27511
    United States

    Site Not Available

  • Hickory, NC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Wake Forest, NC

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Winston Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Winston-Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Winston-Salem, NC

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Tulsa, Oklahoma

    Tulsa, Oklahoma 74114
    United States

    Site Not Available

  • Portland, OR

    Portland, Oregon 97221
    United States

    Site Not Available

  • Portland, Oregon

    Portland, Oregon 97225
    United States

    Site Not Available

  • Salem, Oregon

    Salem, Oregon 97302
    United States

    Site Not Available

  • Springfield, OR

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Portland, OR

    Portland 5746545, Oregon 5744337 97221
    United States

    Site Not Available

  • Bethlehem, PA

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Erie, PA

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Aiken, SC

    Aiken, South Carolina 29802
    United States

    Site Not Available

  • Beaufort, NC

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Beaufort, SC

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Bluffton, NC

    Bluffton, South Carolina 29910
    United States

    Site Not Available

  • Charleston, SC

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Florence, SC

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Ladson, NC

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Ladson, SC

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • West Columbia, SC

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Beaufort, NC

    Beaufort 4570284, South Carolina 4597040 29902
    United States

    Site Not Available

  • Ladson, SC

    Ladson 4584277, South Carolina 4597040 29456
    United States

    Site Not Available

  • Germantown, TN

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Hixson, TN

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Johnson City, TN

    Johnson City, Tennessee 37604
    United States

    Site Not Available

  • Knoxville, TN

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Nashville, TN

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Abilene, TX

    Abilene, Texas 79606
    United States

    Site Not Available

  • Amarillo, TX

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Arlington, TX

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin, TX

    Austin, Texas 78705
    United States

    Site Not Available

  • Bellaire, TX

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Burleson, Texas

    Burleson, Texas 76028
    United States

    Site Not Available

  • Dallas, TX

    Dallas, Texas 75231
    United States

    Site Not Available

  • Fort Worth, TX

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Katy, TX

    Katy, Texas 77494
    United States

    Site Not Available

  • Plano, TX

    Plano, Texas 75075
    United States

    Site Not Available

  • Round Rock, TX

    Round Rock, Texas 78681
    United States

    Site Not Available

  • San Antonio, TX

    San Antonio, Texas 78240
    United States

    Site Not Available

  • San Marcos, Texas

    San Marcos, Texas 78666
    United States

    Site Not Available

  • Schertz, TX

    Schertz, Texas 78154
    United States

    Site Not Available

  • The Woodlands, TX

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Willow Park, TX

    Willow Park, Texas 76087
    United States

    Site Not Available

  • Salt Lake City, UT

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • West Jordan, Utah

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Lynchburg, VA

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Richmond, VA

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Bellevue, Washington

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Burlington, Washington

    Burlington, Washington 98233
    United States

    Site Not Available

  • Spokane, WA

    Spokane, Washington 99204
    United States

    Site Not Available

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