A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

Last updated: August 8, 2025
Sponsor: EyeBiotech Ltd.
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Macular Edema

Treatment

EYE103

Ranibizumab

Clinical Study ID

NCT06571045
EYE-RES-102
  • Ages > 18
  • All Genders

Study Summary

EYE-RES-102 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: 984
Treatment Group(s): 2
Primary Treatment: EYE103
Phase: 2/3
Study Start date:
August 07, 2024
Estimated Completion Date:
December 31, 2027

Study Description

EYE-RES-102 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

  • Buenos Aires, Argentina

    Caba, Buenos Aires 1015
    Argentina

    Site Not Available

  • Caba, Buenos Aires, Argentina

    Caba, Buenos Aires C1116ABA
    Argentina

    Site Not Available

  • Cordoba, Argentina

    Córdoba, Cordoba 5000
    Argentina

    Site Not Available

  • Santa Fe, Argentina

    Rosario, Santa Fe S2000DSK
    Argentina

    Site Not Available

  • Ciudad de Cordoba, Argentina

    Ciudad de Cordoba, X5000AAJ
    Argentina

    Site Not Available

  • Sydney Retina Clinic

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Sydney, Australia

    Sydney, New South Wales 2135
    Australia

    Site Not Available

  • Albury, Australia

    Albury, 2640
    Australia

    Site Not Available

  • Parramatta, Australia

    Parramatta, 2150
    Australia

    Site Not Available

  • Graz, Austria

    Graz, 8036
    Austria

    Site Not Available

  • Innsbruck, Austria

    Innsbruck, 6020
    Austria

    Site Not Available

  • Vienna, Austria

    Vienna, 1140
    Austria

    Site Not Available

  • Barranquilla, Colombia

    Barranquilla, Atlantico 80002
    Colombia

    Site Not Available

  • Bogota, Columbia

    Bogotá, Columbia 110231
    Colombia

    Site Not Available

  • Cali, Colombia

    Cali, Valle del Cauca 760042
    Colombia

    Site Not Available

  • Medellin, Colombia

    Medellín, 50016
    Colombia

    Site Not Available

  • Osijek, Croatia

    Osijek, 31000
    Croatia

    Site Not Available

  • Mlada Boleslav, Czechia

    Mladá Boleslav, 293 01
    Czechia

    Site Not Available

  • Nachod, Czechia

    Náchod, 547 01
    Czechia

    Site Not Available

  • Prague, Czechia

    Prague, 1150/50
    Czechia

    Site Not Available

  • Cedex, France

    Dijon, Cedex 21079
    France

    Site Not Available

  • Creteil, France

    Créteil, 94010
    France

    Site Not Available

  • Lyon, France

    Lyon, 69004
    France

    Site Not Available

  • Marseille, France

    Marseille, 13008
    France

    Site Not Available

  • Paris, France

    Paris, 75006
    France

    Site Not Available

  • Saint Cyr sur Loire, France

    Saint-Cyr-sur-Loire, 37540
    France

    Site Not Available

  • Frankfurt, Germany

    Frankfurt, 60590
    Germany

    Site Not Available

  • Hanover, Germany

    Hanover, 30625
    Germany

    Site Not Available

  • Munchen, Germany

    München, 80336
    Germany

    Site Not Available

  • Munster, Germany

    Münster, 48145
    Germany

    Site Not Available

  • Budapest, Hungary

    Budapest, H-1106
    Hungary

    Site Not Available

  • Budapest, Hungry

    Budapest, H-1133
    Hungary

    Site Not Available

  • Debrecen, Hungary

    Debrecen, H-4032
    Hungary

    Site Not Available

  • Pecs, Hungary

    Pecs, H-7621
    Hungary

    Site Not Available

  • Szeged, Hungary

    Szeged, H-6720
    Hungary

    Site Not Available

  • Zalaegerszeg, Hungary

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Beer Yakov, Israel

    Be'er Ya'aqov, 70300
    Israel

    Site Not Available

  • Haifa, Israel

    Haifa, 3436212
    Israel

    Site Not Available

  • Jerusalem, Israel

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Petah Tikva, Israel

    Petah tikva, 49100
    Israel

    Site Not Available

  • Rehovot, Israel

    Reẖovot, 76100
    Israel

    Site Not Available

  • Tel Aviv, Israel

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Bologna, Italy

    Bologna, 40138
    Italy

    Site Not Available

  • Firenze, Italy

    Firenze, 50139
    Italy

    Site Not Available

  • Milano, Italy

    Milano, 20132
    Italy

    Site Not Available

  • Roma, Italy

    Roma, 00168
    Italy

    Site Not Available

  • Rome, Italy

    Rome, 81.00133
    Italy

    Site Not Available

  • Udine, Italy

    Udine, 33100
    Italy

    Site Not Available

  • Riga, Latvia

    Riga, LV1002
    Latvia

    Site Not Available

  • Gdansk, Poland

    Gdańsk, Gdansk 80-809
    Poland

    Site Not Available

  • Bialystok, Poland

    Białystok, 15-866
    Poland

    Site Not Available

  • Bydgoszcz, Poland

    Bydgoszcz, 85-631
    Poland

    Site Not Available

  • Katowice, Poland

    Katowice, 40-594
    Poland

    Site Not Available

  • Krakow, Poland

    Kraków, 31-501
    Poland

    Site Not Available

  • Olsztyn, Poland

    Olsztyn, 10-424
    Poland

    Site Not Available

  • Tarnowskie Gory, Poland

    Tarnowskie Góry, 42-600
    Poland

    Site Not Available

  • Coimbra, Portugal

    Coimbra, 3000-548
    Portugal

    Site Not Available

  • Porto, Portugal

    Porto, 4200-319
    Portugal

    Site Not Available

  • Arecibo, PR

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Trebisov, Slovakia

    Trebišov, 075 01
    Slovakia

    Site Not Available

  • Trencin, Slovakia

    Trenčín, 911 01
    Slovakia

    Site Not Available

  • Zilina, Slovakia

    Žilina, 012 07
    Slovakia

    Site Not Available

  • Valencia, Spain

    Burjassot, Valencia 46100
    Spain

    Site Not Available

  • Barcelona, Spain

    Barcelona, 08022
    Spain

    Site Not Available

  • Santiago de Compostela, Spain

    Santiago De Compostela, 15706
    Spain

    Site Not Available

  • Sevilla, Spain

    Sevilla, 41009
    Spain

    Site Not Available

  • Zaragoza, Spain

    Zaragoza, 50009
    Spain

    Site Not Available

  • Ankara, Turkey

    Ankara, 06490
    Turkey

    Site Not Available

  • Balcova, Turkey

    Balçova, 35330
    Turkey

    Site Not Available

  • London, UK

    London, Middlesex NW10 7NS
    United Kingdom

    Site Not Available

  • York, United Kingdom

    York, UnitedKingdom YO10 4DZ
    United Kingdom

    Site Not Available

  • Bradford, United Kingdom

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Bristol, UK

    Bristol, BS1 2LX
    United Kingdom

    Site Not Available

  • Liverpool, United Kingdom

    Liverpool, L7 8YA
    United Kingdom

    Site Not Available

  • Sunderland, United Kingdom

    Sunderland, SR2 9HP
    United Kingdom

    Site Not Available

  • Wolverhamptom, United Kingdom

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Scottsdale

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Fayetteville, Arkansas

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Springdale, Arkansas

    Springdale, Arkansas 72764
    United States

    Site Not Available

  • Bakersfield, CA

    Bakersfield, California 93309
    United States

    Site Not Available

  • Glendale, CA

    Glendale, California 91204
    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

  • Colorado Springs, CO

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Denver, Colorado

    Denver, Colorado 80210
    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

  • 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, Florida

    Orlando, Florida 32806
    United States

    Site Not Available

  • Plantation, FL

    Plantation, Florida 33324
    United States

    Site Not Available

  • Saint Petersburg, FL

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Sarasota, FL

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Tallahassee, FL

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Tampa, FL

    Tampa, Florida 33617
    United States

    Site Not Available

  • Winter Haven, FL

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Lemont, IL

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Springfield, Illinois

    Springfield, Illinois 62702
    United States

    Site Not Available

  • West Des Moines, IA

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Lenexa, Kansas

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Wichita, Kansas

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Portland, Maine

    Portland, Maine 04101
    United States

    Site Not Available

  • Hagerstown, MD

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Springfield,MA

    Springfield, Massachusetts 01107
    United States

    Site Not Available

  • Grand Rapids, Michigan

    Grand Rapids, Michigan 49546
    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

  • Bloomfield, NJ

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • Cherry Hill, NJ

    Cherry Hill, New Jersey 08034
    United States

    Site Not Available

  • Liverpool, NY

    Liverpool, New York 13088
    United States

    Site Not Available

  • Oceanside, NY

    Oceanside, New York 11572
    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

  • Hickory, NC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Wake Forest, MC

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Winston Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Cleveland, OH

    Cleveland, Ohio 44130
    United States

    Site Not Available

  • Cleveland, Ohio

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Youngstown, Ohio

    Youngstown, Ohio 44505
    United States

    Site Not Available

  • Edmond, OK

    Edmond, Oklahoma 73013
    United States

    Site Not Available

  • Portland, OR

    Portland, Oregon 97221
    United States

    Site Not Available

  • Springfield, Oregon

    Springfield, Oregon 97477
    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

  • Beaufort, SC

    Beaufort, South Carolina 29902
    United States

    Site Not Available

  • Florence, SC

    Florence, South Carolina 29501
    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

  • Germantown, TN

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Hixson, Tennessee

    Hixson, Tennessee 37343
    United States

    Site Not Available

  • Johnson City, Tennessee

    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 79109
    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

  • Beaumont, TX

    Beaumont, Texas 77707
    United States

    Site Not Available

  • Bellaire, TX

    Bellaire, Texas 77401
    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

  • Schertz, Texas

    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, Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Lynchburg, VA

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Richmond, Virginia

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Spokane, WA

    Spokane, Washington 99204
    United States

    Site Not Available

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