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

Last updated: May 19, 2025
Sponsor: EyeBiotech Ltd.
Overall Status: Active - 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 HbA1c of ≤12%.

  • Have a decrease in vision in the study eye determined by the investigator to beprimarily the result of 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 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 90days of the Screening visit

Study Design

Total Participants: 960
Treatment Group(s): 2
Primary Treatment: Ranibizumab
Phase: 2/3
Study Start date:
April 16, 2025
Estimated Completion Date:
June 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 ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Connect with a study center

  • Arecibo, PR

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Scottsdale, AZ

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Fayetteville, AR

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Bakersfield, CA

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Modesto, CA

    Modesto, California 95356
    United States

    Active - Recruiting

  • Mountain View, CA

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Redlands, CA

    Redlands, California 92374
    United States

    Active - Recruiting

  • Sacramento, CA

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Santa Ana

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Santa Ana, CA

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Colorado Springs, CO

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Durango, CO

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Danbury, CT

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • Manchester, CT

    Manchester, Connecticut 06042
    United States

    Active - Recruiting

  • Waterford, CT

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Waterford,CT

    Waterford, Connecticut 06385
    United States

    Active - Recruiting

  • Deerfield Beach, FL

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • Fort Lauderdale, FL

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Fort Myers, FL

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Gainesville, FL

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Orlando, FL

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Plantation, FL

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Saint Petersburg, FL

    Saint Petersburg, Florida 33711
    United States

    Active - Recruiting

  • Sarasota, FL

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Tallahassee, FL

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Tampa, FL

    Tampa, Florida 33617
    United States

    Active - Recruiting

  • Winter Haven, FL

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Lemont, IL

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Oak Park, IL

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Springfield, IL

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Lenexa, KS

    Lenexa, Kansas 66215
    United States

    Active - Recruiting

  • Portland, ME

    Portland, Maine 04101
    United States

    Active - Recruiting

  • Hagerstown, MD

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Towson, MD

    Towson, Maryland 21204
    United States

    Active - Recruiting

  • Springfield,MA

    Springfield, Massachusetts 01107
    United States

    Active - Recruiting

  • Grand Rapids, MI

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Edina, MN

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Minneapolis, MN

    Minneapolis, Minnesota 55435
    United States

    Active - Recruiting

  • Madison, MS

    Madison, Mississippi 39110
    United States

    Active - Recruiting

  • Bloomfield, NJ

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • Cherry Hill, NJ

    Cherry Hill, New Jersey 08034
    United States

    Active - Recruiting

  • Liverpool, NY

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Rochester, NY

    Rochester, New York 14620
    United States

    Active - Recruiting

  • Asheville, NC

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Hickory, NC

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • Wake Forest, NC

    Wake Forest, North Carolina 27587
    United States

    Active - Recruiting

  • Winston Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Winston-Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Portland, OR

    Portland, Oregon 97221
    United States

    Active - Recruiting

  • Springfield, OR

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Bethlehem, PA

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Erie, PA

    Erie, Pennsylvania 16507
    United States

    Active - Recruiting

  • Beaufort, NC

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Beaufort, SC

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Florence, SC

    Florence, South Carolina 29501
    United States

    Active - Recruiting

  • Ladson, NC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Ladson, SC

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • West Columbia, SC

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • Germantown, TN

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Hixson, TN

    Hixson, Tennessee 37343
    United States

    Active - Recruiting

  • Johnson City, TN

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Knoxville, TN

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Nashville, TN

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Abilene, TX

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Amarillo, TX

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Arlington, TX

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Austin, TX

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Bellaire, TX

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Dallas, TX

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Fort Worth, TX

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Katy, TX

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Plano, TX

    Plano, Texas 75075
    United States

    Active - Recruiting

  • Round Rock, TX

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • San Antonio, TX

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Schertz, TX

    Schertz, Texas 78154
    United States

    Active - Recruiting

  • The Woodlands, TX

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Willow Park, TX

    Willow Park, Texas 76087
    United States

    Active - Recruiting

  • Salt Lake City, UT

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Lynchburg, VA

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Richmond, VA

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Spokane, WA

    Spokane, Washington 99204
    United States

    Active - Recruiting

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