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New eye drug EYE103 takes on standard treatment for Diabetes-Related vision loss

NCT ID NCT06957080

Disease control Sponsor: EyeBiotech Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests a new drug called EYE103 (Restoret) against an existing treatment, ranibizumab (Lucentis), for people with diabetic macular edema, a common cause of vision loss in diabetes. About 1,054 participants receive injections into the eye every 4 weeks for a year, then less often based on their response. The goal is to see if EYE103 improves vision more than the current standard.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EYE103 (Restoret) and ranibizumab (Lucentis)
What this could lead to
If EYE103 works better than ranibizumab, it could offer a new treatment option to improve vision in people with diabetic macular edema.
What could go wrong
This is a mid-to-late stage trial, but results are not yet known. EYE103 may not prove superior to the existing drug, and all participants receive frequent eye injections, which carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

1,054 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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 hemoglobin A1c (HbA1c) of ≤12%. * Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME). Exclusion Criteria: * 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 in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (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 the Screening visit

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema (DME)

Contacts and locations

Locations

  • Abilene, TX

    Abilene, Texas, 79606, United States

  • Aiken, SC

    Aiken, South Carolina, 29802, United States

  • Albuquerque, New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Amagasaki, Japan

    Amagasaki, Hyōgo, 660-8550, Japan

  • Amarillo, TX

    Amarillo, Texas, 79106, United States

  • Aparecida De Goiania, Brazil

    Aparecida de Goiânia, 74210-010, Brazil

  • Aparecida de Goiania, Brazil

    Aparecida de Goiânia, 74980-010, Brazil

  • Arecibo, PR

    Arecibo, 00612, Puerto Rico

  • Arlington, TX

    Arlington, Texas, 76012, United States

  • Asahikawa, Japan

    Asahikawa, Hokkaido, 078-8510, Japan

  • Asheville, NC

    Asheville, North Carolina, 28803, United States

  • Assis, Brazil

    Assis, 19814-470, Brazil

  • Austin, TX

    Austin, Texas, 78705, United States

  • Bakersfield, CA

    Bakersfield, California, 93309, United States

  • Baltimore, Maryland

    Baltimore, Maryland, 21209, United States

  • Barranquilla, Colombia

    Barranquilla, 080001, Colombia

  • Beaufort, NC

    Beaufort, South Carolina, 29902, United States

  • Beaufort, SC

    Beaufort, South Carolina, 29902, United States

  • Bellaire, TX

    Bellaire, Texas, 77401, United States

  • Bellevue, Washington

    Bellevue, Washington, 98004, United States

  • Belo Horizonte, Brazil

    Belo Horizonte, 30330-000, Brazil

  • Bethlehem, PA

    Bethlehem, Pennsylvania, 18017, United States

  • Bloomfield, NJ

    Bloomfield, New Jersey, 07003, United States

  • Bluffton, NC

    Bluffton, South Carolina, 29910, United States

  • Blumenau, Brazil

    Blumenau, 89010-204, Brazil

  • Bogata, Colombia

    Bogotá, 110231, Colombia

  • 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

  • Burleson, Texas

    Burleson, Texas, 76028, United States

  • Burlington, Washington

    Burlington, Washington, 98233, United States

  • Cali, Colombia

    Cali, 760042, Colombia

  • Cary, North Carolina

    Cary, North Carolina, 27511, United States

  • Charleston, SC

    Charleston, South Carolina, 29414, United States

  • Cherry Hill, NJ

    Cherry Hill, New Jersey, 08034, United States

  • Colorado Springs, CO

    Colorado Springs, Colorado, 80909, United States

  • Cordoba, Argentina

    Córdoba, X5000AAJ, Argentina

  • Cordoba, Argentina

    Córdoba, X5000, Argentina

  • Dallas, TX

    Dallas, Texas, 75231, United States

  • Danbury, CT

    Danbury, Connecticut, 06810, United States

  • Deerfield Beach, FL

    Deerfield Beach, Florida, 33064, United States

  • Denver, CO

    Denver, Colorado, 80012, United States

  • Durango, CO

    Durango, Colorado, 81303, United States

  • Edina, MN

    Edina, Minnesota, 55435, United States

  • Encino, California

    Encino, California, 91436, United States

  • Erie, PA

    Erie, Pennsylvania, 16507, United States

  • Fayetteville, AR

    Fayetteville, Arkansas, 72703, United States

  • Florence, SC

    Florence, South Carolina, 29501, United States

  • Fort Lauderdale, FL

    Fort Lauderdale, Florida, 33308, United States

  • Fort Myers, FL

    Fort Myers, Florida, 33912, United States

  • Fort Worth, TX

    Fort Worth, Texas, 76104, United States

  • Fukuoka-shi, Japan

    Fukuoka, Fukuoka, 812-0011, Japan

  • Fukuoka-shi, Japan

    Fukuoka, Higashi-ku Fukuoka, 811-0213, Japan

  • Fukushima, Japan

    Fukushima, 960-1295, Japan

  • Gainesville, FL

    Gainesville, Florida, 32607, United States

  • Germantown, TN

    Germantown, Tennessee, 38138, United States

  • Gilbert, Arizona

    Gilbert, Arizona, 85297, United States

  • Grand Rapids, MI

    Grand Rapids, Michigan, 49546, United States

  • Great Neck, New York

    Great Neck, New York, 11021, United States

  • Hachioji, Japan

    Hachiōji, Tokyo, 193-0998, Japan

  • Hagerstown, MD

    Hagerstown, Maryland, 21740, United States

  • Hauppauge, New York

    Hauppauge, New York, 11788, United States

  • Henderson, Nevada

    Henderson, Nevada, 89052, United States

  • Hickory, NC

    Hickory, North Carolina, 28602, United States

  • Hirosaki, Japan

    Hirosaki, Aomori, 036-8563, Japan

  • Hixson, TN

    Hixson, Tennessee, 37343, United States

  • Johnson City, TN

    Johnson City, Tennessee, 37604, United States

  • Joliet, Illinois

    Joliet, Illinois, 60435, United States

  • Kagoshima City, Japan

    Kagoshima, Kagoshima-ken, 890-8520, Japan

  • Katy, TX

    Katy, Texas, 77494, United States

  • Kita-gun, Japan

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Knoxville, TN

    Knoxville, Tennessee, 37922, United States

  • Kurume City, Japan

    Kurume, Fukuoka, 830-8543, Japan

  • Ladson, NC

    Ladson, South Carolina, 29456, United States

  • Ladson, SC

    Ladson, South Carolina, 29456, United States

  • Lemont, IL

    Lemont, Illinois, 60439, United States

  • Lenexa, KS

    Lenexa, Kansas, 66215, United States

  • Liverpool, NY

    Liverpool, New York, 13088, United States

  • Lynchburg, VA

    Lynchburg, Virginia, 24502, United States

  • Madison, MS

    Madison, Mississippi, 39110, United States

  • Manchester, CT

    Manchester, Connecticut, 06042, United States

  • Medelin, Colombia

    Medellín, 050021, Colombia

  • Medellin, Colombia

    Medellín, 50021, Colombia

  • Meguro-ku, Japan

    Meguro-ku, Tokyo, 152-8902, Japan

  • Minneapolis, MN

    Minneapolis, Minnesota, 55435, United States

  • Mito, Japan

    Mito, Ibaraki, 310-0845, Japan

  • Miyazaki, Japan

    Miyazaki, 889-1692, Japan

  • Modesto, CA

    Modesto, California, 95356, United States

  • Mountain View, CA

    Mountain View, California, 94040, United States

  • Nagoya City, Japan

    Nagoya, Aichi-ken, 466-8560, Japan

  • Nashville, TN

    Nashville, Tennessee, 37203, United States

  • New York, NY

    New York, New York, 10022, United States

  • Oak Park, IL

    Oak Park, Illinois, 60304, United States

  • Orlando, FL

    Orlando, Florida, 32806, United States

  • Osaka, Japan

    Osaka, 530-8480, Japan

  • Osaka, Japan

    Osaka, 540-0006, Japan

  • Osaka, Japan

    Osaka, 545-8586, Japan

  • Phoenix, Arizona

    Phoenix, Arizona, 85020, United States

  • Plano, TX

    Plano, Texas, 75075, United States

  • Plantation, FL

    Plantation, Florida, 33324, United States

  • Portland, ME

    Portland, Maine, 04101, United States

  • Portland, OR

    Portland, Oregon, 97221, United States

  • Portland, Oregon

    Portland, Oregon, 97225, United States

  • Porto Alegre, Brazil

    Porto Alegre, 90.440-051, Brazil

  • Redlands, CA

    Redlands, California, 92374, United States

  • Richmond, VA

    Richmond, Virginia, 23235, United States

  • Rochester, NY

    Rochester, New York, 14620, United States

  • Round Rock, TX

    Round Rock, Texas, 78681, United States

  • Sacramento, CA

    Sacramento, California, 95825, United States

  • Sacramento, CA

    Sacramento, California, 95841, United States

  • Saint Petersburg, FL

    St. Petersburg, Florida, 33711, United States

  • Sakura, Japan

    Sakura, Chiba, 285-8741, Japan

  • Salem, Oregon

    Salem, Oregon, 97302, United States

  • Salt Lake City, UT

    Salt Lake City, Utah, 84107, United States

  • Salta, Argentina

    Salta, 4400, Argentina

  • Salta, Argentina

    Salta, A4400, Argentina

  • San Antonio, TX

    San Antonio, Texas, 78240, United States

  • San Juan, Puerto Rico

    San Juan, 00921, Puerto Rico

  • San Marcos, Texas

    San Marcos, Texas, 78666, United States

  • Santa Ana

    Santa Ana, California, 92705, United States

  • Santa Ana, CA

    Santa Ana, California, 92705, United States

  • Santa Fe, Argentina

    Santa Fe, S2000, Argentina

  • Sao Paulo, Brazil

    São Paulo, 04023-062, Brazil

  • Sao Paulo, Brazil

    São Paulo, 04038-032, Brazil

  • Sarasota, FL

    Sarasota, Florida, 34232, United States

  • Schertz, TX

    Schertz, Texas, 78154, United States

  • Scottsdale, AZ

    Scottsdale, Arizona, 85255, United States

  • Shimotsuke-shi, Japan

    Shimotsuke-shi, Tochigi, 329-0498, Japan

  • Sorocaba, Brazil

    Sorocaba, 18031-060, Brazil

  • Spokane, WA

    Spokane, Washington, 99204, United States

  • Springfield, IL

    Springfield, Illinois, 62702, United States

  • Springfield, OR

    Springfield, Oregon, 97477, United States

  • Springfield,MA

    Springfield, Massachusetts, 01107, United States

  • Taito-ku, Japan

    Taito-ku, Tokyo, 111-0051, Japan

  • Tallahassee, FL

    Tallahassee, Florida, 32308, United States

  • Tampa, FL

    Tampa, Florida, 33609, United States

  • Tampa, FL

    Tampa, Florida, 33617, United States

  • The Woodlands, TX

    The Woodlands, Texas, 77384, United States

  • Tokorozawa-shi, Japan

    Tokorozawa-shi, Saitama, 359-8513, Japan

  • Tokushima, Japan

    Tokushima, 770-8503, Japan

  • Tokyo, Japan

    Tokyo, 101-8309, Japan

  • Towson, MD

    Towson, Maryland, 21204, United States

  • Tulsa, Oklahoma

    Tulsa, Oklahoma, 74114, United States

  • Ube-shi, Japan

    Ube-shi, Yamaguchi, 755-8505, Japan

  • Vitoria, Brazil

    Vitória, 29055-450, Brazil

  • Wake Forest, NC

    Wake Forest, North Carolina, 27587, United States

  • Waterford, CT

    Waterford, Connecticut, 06385, United States

  • Waterford,CT

    Waterford, Connecticut, 06385, United States

  • West Columbia, SC

    West Columbia, South Carolina, 29169, United States

  • West Des Moines, IA

    West Des Moines, Iowa, 50266, United States

  • West Jordan, Utah

    West Jordan, Utah, 84088, United States

  • Wichita, Kansas

    Wichita, Kansas, 67214, United States

  • Willow Park, TX

    Willow Park, Texas, 76087, United States

  • Winston Salem, NC

    Winston-Salem, North Carolina, 27103, United States

  • Winston-Salem, NC

    Winston-Salem, North Carolina, 27103, United States

  • Winter Haven, FL

    Winter Haven, Florida, 33880, United States

  • Yamagata, Japan

    Yamagata, 990-9585, Japan

  • Yoshida-gun, Japan

    Yoshida-gun, Fukui, 910-1193, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.