A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
BAROLO
A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema
1 other identifier
interventional
1,054
6 countries
164
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Typical duration for phase_2
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedStudy Start
First participant enrolled
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
January 6, 2026
January 1, 2026
1.9 years
April 16, 2025
January 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
52 Weeks
Secondary Outcomes (2)
Changes in structural outcomes measured using OCT CST
Duration of the study, through Week 104
Changes in visual outcomes measured using the standardized ETDRS chart
Duration of the study, through Week 104
Study Arms (3)
EYE103 Low Dose Treatment Arm
EXPERIMENTALEYE103 Low Dose Treatment Arm
EYE103 High Dose Treatment Arm
EXPERIMENTALEYE103 High Dose Treatment Arm
Ranibizumab Treatment Arm
ACTIVE COMPARATORRanibizumab Treatment Arm
Interventions
EYE103 is a humanized antibody formulated for intravitreal administration
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
Eligibility Criteria
You may qualify if:
- 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 HbA1c of ≤12%.
- Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
You may not qualify if:
- Be pregnant or breastfeeding
- 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
- 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 treatments within 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 90 days of the Screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EyeBiotech Ltd.lead
Study Sites (164)
Gilbert, Arizona
Gilbert, Arizona, 85297, United States
Phoenix, Arizona
Phoenix, Arizona, 85020, United States
Scottsdale, AZ
Scottsdale, Arizona, 85255, United States
Fayetteville, AR
Fayetteville, Arkansas, 72703, United States
Bakersfield, CA
Bakersfield, California, 93309, United States
Encino, California
Encino, California, 91436, United States
Modesto, CA
Modesto, California, 95356, United States
Mountain View, CA
Mountain View, California, 94040, United States
Redlands, CA
Redlands, California, 92374, United States
Sacramento, CA
Sacramento, California, 95825, United States
Sacramento, CA
Sacramento, California, 95841, United States
Santa Ana, CA
Santa Ana, California, 92705, United States
Santa Ana
Santa Ana, California, 92705, United States
Colorado Springs, CO
Colorado Springs, Colorado, 80909, United States
Denver, CO
Denver, Colorado, 80012, United States
Durango, CO
Durango, Colorado, 81303, United States
Danbury, CT
Danbury, Connecticut, 06810, United States
Manchester, CT
Manchester, Connecticut, 06042, United States
Waterford, CT
Waterford, Connecticut, 06385, United States
Waterford,CT
Waterford, Connecticut, 06385, United States
Deerfield Beach, FL
Deerfield Beach, Florida, 33064, United States
Fort Lauderdale, FL
Fort Lauderdale, Florida, 33308, United States
Fort Myers, FL
Fort Myers, Florida, 33912, United States
Gainesville, FL
Gainesville, Florida, 32607, United States
Orlando, FL
Orlando, Florida, 32806, United States
Plantation, FL
Plantation, Florida, 33324, United States
Sarasota, FL
Sarasota, Florida, 34232, United States
Saint Petersburg, FL
St. Petersburg, Florida, 33711, United States
Tallahassee, FL
Tallahassee, Florida, 32308, United States
Tampa, FL
Tampa, Florida, 33609, United States
Tampa, FL
Tampa, Florida, 33617, United States
Winter Haven, FL
Winter Haven, Florida, 33880, United States
Joliet, Illinois
Joliet, Illinois, 60435, United States
Lemont, IL
Lemont, Illinois, 60439, United States
Oak Park, IL
Oak Park, Illinois, 60304, United States
Springfield, IL
Springfield, Illinois, 62702, United States
West Des Moines, IA
West Des Moines, Iowa, 50266, United States
Lenexa, KS
Lenexa, Kansas, 66215, United States
Wichita, Kansas
Wichita, Kansas, 67214, United States
Portland, ME
Portland, Maine, 04101, United States
Baltimore, Maryland
Baltimore, Maryland, 21209, United States
Hagerstown, MD
Hagerstown, Maryland, 21740, United States
Towson, MD
Towson, Maryland, 21204, United States
Springfield,MA
Springfield, Massachusetts, 01107, United States
Grand Rapids, MI
Grand Rapids, Michigan, 49546, United States
Edina, MN
Edina, Minnesota, 55435, United States
Minneapolis, MN
Minneapolis, Minnesota, 55435, United States
Madison, MS
Madison, Mississippi, 39110, United States
Henderson, Nevada
Henderson, Nevada, 89052, United States
Bloomfield, NJ
Bloomfield, New Jersey, 07003, United States
Cherry Hill, NJ
Cherry Hill, New Jersey, 08034, United States
Albuquerque, New Mexico
Albuquerque, New Mexico, 87109, United States
Great Neck, New York
Great Neck, New York, 11021, United States
Hauppauge, New York
Hauppauge, New York, 11788, United States
Liverpool, NY
Liverpool, New York, 13088, United States
New York, NY
New York, New York, 10022, United States
Rochester, NY
Rochester, New York, 14620, United States
Asheville, NC
Asheville, North Carolina, 28803, United States
Cary, North Carolina
Cary, North Carolina, 27511, United States
Hickory, NC
Hickory, North Carolina, 28602, United States
Wake Forest, NC
Wake Forest, North Carolina, 27587, United States
Winston Salem, NC
Winston-Salem, North Carolina, 27103, United States
Winston-Salem, NC
Winston-Salem, North Carolina, 27103, United States
Tulsa, Oklahoma
Tulsa, Oklahoma, 74114, United States
Portland, OR
Portland, Oregon, 97221, United States
Portland, Oregon
Portland, Oregon, 97225, United States
Salem, Oregon
Salem, Oregon, 97302, United States
Springfield, OR
Springfield, Oregon, 97477, United States
Bethlehem, PA
Bethlehem, Pennsylvania, 18017, United States
Erie, PA
Erie, Pennsylvania, 16507, United States
Aiken, SC
Aiken, South Carolina, 29802, United States
Beaufort, NC
Beaufort, South Carolina, 29902, United States
Beaufort, SC
Beaufort, South Carolina, 29902, United States
Bluffton, NC
Bluffton, South Carolina, 29910, United States
Charleston, SC
Charleston, South Carolina, 29414, United States
Florence, SC
Florence, South Carolina, 29501, United States
Ladson, NC
Ladson, South Carolina, 29456, United States
Ladson, SC
Ladson, South Carolina, 29456, United States
West Columbia, SC
West Columbia, South Carolina, 29169, United States
Germantown, TN
Germantown, Tennessee, 38138, United States
Hixson, TN
Hixson, Tennessee, 37343, United States
Johnson City, TN
Johnson City, Tennessee, 37604, United States
Knoxville, TN
Knoxville, Tennessee, 37922, United States
Nashville, TN
Nashville, Tennessee, 37203, United States
Abilene, TX
Abilene, Texas, 79606, United States
Amarillo, TX
Amarillo, Texas, 79106, United States
Arlington, TX
Arlington, Texas, 76012, United States
Austin, TX
Austin, Texas, 78705, United States
Bellaire, TX
Bellaire, Texas, 77401, United States
Burleson, Texas
Burleson, Texas, 76028, United States
Dallas, TX
Dallas, Texas, 75231, United States
Fort Worth, TX
Fort Worth, Texas, 76104, United States
Katy, TX
Katy, Texas, 77494, United States
Plano, TX
Plano, Texas, 75075, United States
Round Rock, TX
Round Rock, Texas, 78681, United States
San Antonio, TX
San Antonio, Texas, 78240, United States
San Marcos, Texas
San Marcos, Texas, 78666, United States
Schertz, TX
Schertz, Texas, 78154, United States
The Woodlands, TX
The Woodlands, Texas, 77384, United States
Willow Park, TX
Willow Park, Texas, 76087, United States
Salt Lake City, UT
Salt Lake City, Utah, 84107, United States
West Jordan, Utah
West Jordan, Utah, 84088, United States
Lynchburg, VA
Lynchburg, Virginia, 24502, United States
Richmond, VA
Richmond, Virginia, 23235, United States
Bellevue, Washington
Bellevue, Washington, 98004, United States
Burlington, Washington
Burlington, Washington, 98233, United States
Spokane, WA
Spokane, Washington, 99204, United States
Buenos Aires, Argentina
Buenos Aires, 1015, Argentina
Buenos Aires, Argentina
Buenos Aires, 1023, Argentina
Buenos Aires, Argentina
Buenos Aires, 1120, Argentina
Buenos Aires, Argentina
Buenos Aires, B18321XE, Argentina
Buenos Aires, Argentina
Buenos Aires, B1878KDF, Argentina
Buenos Aires, Argentina
Buenos Aires, C1008, Argentina
Buenos Aires, Argentina
Buenos Aires, C1033AAW, Argentina
Buenos Aires, Argentina
Buenos Aires, C1116ABA, Argentina
Buenos Aires, Argentina
Buenos Aires, C1280AEB, Argentina
Cordoba, Argentina
Córdoba, X5000AAJ, Argentina
Cordoba, Argentina
Córdoba, X5000, Argentina
Salta, Argentina
Salta, 4400, Argentina
Salta, Argentina
Salta, A4400, Argentina
Santa Fe, Argentina
Santa Fe, S2000, Argentina
Aparecida De Goiania, Brazil
Aparecida de Goiânia, 74210-010, Brazil
Aparecida de Goiania, Brazil
Aparecida de Goiânia, 74980-010, Brazil
Assis, Brazil
Assis, 19814-470, Brazil
Belo Horizonte, Brazil
Belo Horizonte, 30330-000, Brazil
Blumenau, Brazil
Blumenau, 89010-204, Brazil
Porto Alegre, Brazil
Porto Alegre, 90.440-051, Brazil
Sao Paulo, Brazil
São Paulo, 04023-062, Brazil
Sao Paulo, Brazil
São Paulo, 04038-032, Brazil
Sorocaba, Brazil
Sorocaba, 18031-060, Brazil
Vitoria, Brazil
Vitória, 29055-450, Brazil
Barranquilla, Colombia
Barranquilla, 080001, Colombia
Bogata, Colombia
Bogotá, 110231, Colombia
Cali, Colombia
Cali, 760042, Colombia
Medelin, Colombia
Medellín, 050021, Colombia
Medellin, Colombia
Medellín, 50021, Colombia
Nagoya City, Japan
Nagoya, Aichi-ken, 466-8560, Japan
Hirosaki, Japan
Hirosaki, Aomori, 036-8563, Japan
Sakura, Japan
Sakura, Chiba, 285-8741, Japan
Yoshida-gun, Japan
Yoshida-gun, Fukui, 910-1193, Japan
Fukuoka-shi, Japan
Fukuoka, Fukuoka, 812-0011, Japan
Kurume City, Japan
Kurume, Fukuoka, 830-8543, Japan
Fukuoka-shi, Japan
Fukuoka, Higashi-ku Fukuoka, 811-0213, Japan
Asahikawa, Japan
Asahikawa, Hokkaido, 078-8510, Japan
Amagasaki, Japan
Amagasaki, Hyōgo, 660-8550, Japan
Mito, Japan
Mito, Ibaraki, 310-0845, Japan
Kita-gun, Japan
Kita-gun, Kagawa-ken, 761-0793, Japan
Kagoshima City, Japan
Kagoshima, Kagoshima-ken, 890-8520, Japan
Tokorozawa-shi, Japan
Tokorozawa-shi, Saitama, 359-8513, Japan
Shimotsuke-shi, Japan
Shimotsuke-shi, Tochigi, 329-0498, Japan
Hachioji, Japan
Hachiōji, Tokyo, 193-0998, Japan
Meguro-ku, Japan
Meguro-ku, Tokyo, 152-8902, Japan
Taito-ku, Japan
Taito-ku, Tokyo, 111-0051, Japan
Ube-shi, Japan
Ube-shi, Yamaguchi, 755-8505, Japan
Fukushima, Japan
Fukushima, 960-1295, Japan
Miyazaki, Japan
Miyazaki, 889-1692, Japan
Osaka, Japan
Osaka, 530-8480, Japan
Osaka, Japan
Osaka, 540-0006, Japan
Osaka, Japan
Osaka, 545-8586, Japan
Tokushima, Japan
Tokushima, 770-8503, Japan
Tokyo, Japan
Tokyo, 101-8309, Japan
Yamagata, Japan
Yamagata, 990-9585, Japan
Arecibo, PR
Arecibo, 00612, Puerto Rico
San Juan, Puerto Rico
San Juan, 00921, Puerto Rico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Charles Miller, MD PhD
EyeBiotech Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2025
First Posted
May 4, 2025
Study Start
April 16, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 30, 2028
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share