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: February 18, 2025
Sponsor: EyeBiotech Ltd.
Overall Status: Active - 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: 960
Treatment Group(s): 2
Primary Treatment: EYE103
Phase: 2/3
Study Start date:
August 14, 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 1120
    Argentina

    Active - Recruiting

  • Cordoba, Argentina

    Córdoba, Cordoba 5000
    Argentina

    Active - Recruiting

  • Santa Fe, Argentina

    Rosario, Sante Fe 2000
    Argentina

    Active - Recruiting

  • Sydney Retina Clinic

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Sydney, Australia

    Sydney, New South Wales 2135
    Australia

    Active - Recruiting

  • Graz, Austria

    Graz, 8036
    Austria

    Active - Recruiting

  • Vienna, Austria

    Vienna, 1140
    Austria

    Active - Recruiting

  • Osijek, Croatia

    Osijek, 31000
    Croatia

    Active - Recruiting

  • Mlada Boleslav, Czechia

    Mladá Boleslav, 293 01
    Czechia

    Active - Recruiting

  • Nachod, Czechia

    Náchod, 547 01
    Czechia

    Active - Recruiting

  • Prague, Czechia

    Prague, 1150/50
    Czechia

    Active - Recruiting

  • Cedex, France

    Dijon, Cedex 21079
    France

    Active - Recruiting

  • Creteil, France

    Créteil, 94010
    France

    Active - Recruiting

  • Marseille, France

    Marseille, 13008
    France

    Active - Recruiting

  • Paris, France

    Paris, 75015
    France

    Active - Recruiting

  • Saint Cyr sur Loire, France

    Saint-Cyr-sur-Loire, 37540
    France

    Active - Recruiting

  • Budapest, Hungary

    Budapest, H-1085
    Hungary

    Active - Recruiting

  • Budapest, Hungry

    Budapest, H-1133
    Hungary

    Active - Recruiting

  • Pecs, Hungary

    Pecs, H-7621
    Hungary

    Active - Recruiting

  • Szeged, Hungary

    Szeged, H-6720
    Hungary

    Active - Recruiting

  • Beer Yakov, Israel

    Be'er Ya'aqov, 70300
    Israel

    Active - Recruiting

  • Haifa, Israel

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Jerusalem, Israel

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Petah Tikva, Israel

    Petah tikva, 49100
    Israel

    Active - Recruiting

  • Tel Aviv, Israel

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Firenze, Italy

    Firenze, 50139
    Italy

    Active - Recruiting

  • Milano, Italy

    Milano, 20132
    Italy

    Active - Recruiting

  • Rome, Italy

    Rome, 81.00133
    Italy

    Active - Recruiting

  • Riga, Latvia

    Riga, LV1006
    Latvia

    Active - Recruiting

  • Bydgoszcz, Poland

    Bydgoszcz, 85-631
    Poland

    Active - Recruiting

  • Gdansk, Poland

    Gdańsk, 80-809
    Poland

    Active - Recruiting

  • Olsztyn, Poland

    Olsztyn, 10-424
    Poland

    Active - Recruiting

  • Coimbra, Portugal

    Coimbra, 3000-548
    Portugal

    Active - Recruiting

  • Porto, Portugal

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Arecibo, PR

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Valencia, Spain

    Burjassot, Valencia 46100
    Spain

    Active - Recruiting

  • Barcelona, Spain

    Barcelona, 08195
    Spain

    Active - Recruiting

  • Sevilla, Spain

    Sevilla, 41009
    Spain

    Active - Recruiting

  • London, UK

    London, Middlesex NW10 7NS
    United Kingdom

    Active - Recruiting

  • Bristol, UK

    Bristol, BS1 2LX
    United Kingdom

    Active - Recruiting

  • Scottsdale

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Springdale, Arkansas

    Springdale, Arkansas 72764
    United States

    Active - Recruiting

  • Bakersfield, CA

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Glendale, CA

    Glendale, California 91204
    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 95841
    United States

    Active - Recruiting

  • Santa Ana

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Colorado Springs, CO

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Denver, Colorado

    Denver, Colorado 80210
    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

  • 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

  • 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

  • West Des Moines, IA

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Hagerstown, MD

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Springfield,MA

    Springfield, Massachusetts 01107
    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

  • Oceanside, NY

    Oceanside, New York 11572
    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, MC

    Wake Forest, North Carolina 27587
    United States

    Active - Recruiting

  • Winston Salem, NC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Cleveland, OH

    Cleveland, Ohio 44130
    United States

    Active - Recruiting

  • Edmond, OK

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Portland, OR

    Portland, Oregon 97221
    United States

    Active - Recruiting

  • Bethlehem, PA

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Erie, PA

    Erie, Pennsylvania 16507
    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, 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

  • 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 79109
    United States

    Active - Recruiting

  • Arlington, TX

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Austin, TX

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Beaumont, TX

    Beaumont, Texas 77707
    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

  • The Woodlands, TX

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Willow Park, TX

    Willow Park, Texas 76087
    United States

    Active - Recruiting

  • Lynchburg, VA

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Spokane, WA

    Spokane, Washington 99204
    United States

    Active - Recruiting

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