New eye drug EYE103 takes on lucentis in major trial for Diabetes-Related vision loss

NCT ID NCT06571045

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

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a new drug called EYE103 (Restoret) against an existing treatment, ranibizumab (Lucentis), for people with diabetic macular edema, a condition that causes vision loss in diabetes. About 984 participants will receive injections into the eye every 4 weeks for a year, then less often based on their response. The main goal is to see if EYE103 improves vision more than the current standard treatment.

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 an early combined phase 2/3 trial, so results are not yet proven. The new drug may not be more effective than the existing treatment, and eye injections 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

984 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Dec 2027

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 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

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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
Albury, Australia

Albury, 2640, Australia
Amarillo, TX

Amarillo, Texas, 79106, United States
Amarillo, TX

Amarillo, Texas, 79109, United States
Ankara, Turkey

Ankara, Turkey, 06230, Turkey (Türkiye)
Ankara, Turkey

Ankara, Turkey, 06490, Turkey (Türkiye)
Arecibo, PR

Arecibo, PR, 00612, Puerto Rico
Arlington, TX

Arlington, Texas, 76012, United States
Asheville, NC

Asheville, North Carolina, 28803, United States
Austin, TX

Austin, Texas, 78705, United States
Bakersfield, CA

Bakersfield, California, 93309, United States
Balcova, Turkey

Balçova, Turkey, 35330, Turkey (Türkiye)
Barcelona, Spain

Barcelona, 08021, Spain
Barcelona, Spain

Barcelona, 08022, Spain
Barcelona, Spain

Barcelona, 08035, Spain
Barcelona, Spain

Barcelona, 08195, Spain
Barranquilla, Colombia

Barranquilla, Atlántico, 80002, Colombia
Beaufort, SC

Beaufort, South Carolina, 29902, United States
Beaumont, TX

Beaumont, Texas, 77707, United States
Beer Yakov, Israel

Be’er Ya‘aqov, 70300, Israel
Bellaire, TX

Bellaire, Texas, 77401, United States
Bethlehem, PA

Bethlehem, Pennsylvania, 18017, United States
Bialystok, Poland

Bialystok, 15-866, Poland
Bloomfield, NJ

Bloomfield, New Jersey, 07003, United States
Bogota, Columbia

Bogotá, Columbia, 110231, Colombia
Bologna, Italy

Bologna, 40138, Italy
Bradford, United Kingdom

Bradford, BD9 6RJ, United Kingdom
Bristol, UK

Bristol, BS1 2LX, United Kingdom
Budapest, Hungary

Budapest, H-1062, Hungary
Budapest, Hungary

Budapest, H-1085, Hungary
Budapest, Hungary

Budapest, H-1106, Hungary
Budapest, Hungry

Budapest, H-1133, Hungary
Buenos Aires, Argentina

CABA, Buenos Aires, 1015, Argentina
Buenos Aires, Argentina

CABA, Buenos Aires, 1120, Argentina
Buenos Aires, Argentina

CABA, Buenos Aires, C1033AAW, Argentina
Buenos Aires, Argentina

CABA, 1023, Argentina
Bydgoszcz, Poland

Bydgoszcz, 85-309, Poland
Bydgoszcz, Poland

Bydgoszcz, 85-631, Poland
Caba, Buenos Aires, Argentina

Caba, Buenos Aires, C1116ABA, Argentina
Cali, Colombia

Cali, Valle del Cauca Department, 760042, Colombia
Cedex, France

Dijon, Cedex, 21079, France
Cherry Hill, NJ

Cherry Hill, New Jersey, 08034, United States
Ciudad de Cordoba, Argentina

Córdoba, X5000AAJ, Argentina
Cleveland, OH

Cleveland, Ohio, 44130, United States
Cleveland, Ohio

Cleveland, Ohio, 44122, United States
Coimbra, Portugal

Coimbra, 3000-548, Portugal
Coimbra, Portugal

Coimbra, 3030-163, Portugal
Colorado Springs, CO

Colorado Springs, Colorado, 80909, United States
Cordoba, Argentina

Córdoba, Córdoba Province, 5000, Argentina
Creteil, France

Créteil, 94010, France
Dallas, TX

Dallas, Texas, 75231, United States
Danbury, CT

Danbury, Connecticut, 06810, United States
Debrecen, Hungary

Debrecen, H-4032, Hungary
Deerfield Beach, FL

Deerfield Beach, Florida, 33064, United States
Denver, Colorado

Denver, Colorado, 80210, United States
Edmond, OK

Edmond, Oklahoma, 73013, United States
Erie, PA

Erie, Pennsylvania, 16507, United States
Fayetteville, Arkansas

Fayetteville, Arkansas, 72703, United States
Firenze, Italy

Florence, 50139, Italy
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
Frankfurt, Germany

Frankfurt, 60590, Germany
Gainesville, FL

Gainesville, Florida, 32607, United States
Gdansk, Poland

Gdansk, Gdansk, 80-809, Poland
Gdansk, Poland

Gdansk, 80-809, Poland
Germantown, TN

Germantown, Tennessee, 38138, United States
Glendale, CA

Glendale, California, 91204, United States
Grand Rapids, Michigan

Grand Rapids, Michigan, 49546, United States
Graz, Austria

Graz, 8036, Austria
Hagerstown, MD

Hagerstown, Maryland, 21740, United States
Haifa, Israel

Haifa, 3436212, Israel
Hanover, Germany

Hanover, 30625, Germany
Hickory, NC

Hickory, North Carolina, 28602, United States
Hixson, Tennessee

Hixson, Tennessee, 37343, United States
Innsbruck, Austria

Innsbruck, 6020, Austria
Jerusalem, Israel

Jerusalem, 9112001, Israel
Johnson City, Tennessee

Johnson City, Tennessee, 37604, United States
Katowice, Poland

Katowice, 40-594, Poland
Katy, TX

Katy, Texas, 77494, United States
Knoxville, TN

Knoxville, Tennessee, 37922, United States
Krakow, Poland

Krakow, 31-501, Poland
Ladson, SC

Ladson, South Carolina, 29456, United States
Lemont, IL

Lemont, Illinois, 60439, United States
Lenexa, Kansas

Lenexa, Kansas, 66215, United States
Liverpool, NY

Liverpool, New York, 13088, United States
Liverpool, United Kingdom

Liverpool, L7 8YA, United Kingdom
London, UK

London, Middlesex, NW10 7NS, United Kingdom
Lynchburg, VA

Lynchburg, Virginia, 24502, United States
Lyon, France

Lyon, 69004, France
Madison, MS

Madison, Mississippi, 39110, United States
Manchester, CT

Manchester, Connecticut, 06042, United States
Marseille, France

Marseille, 13008, France
Medellin, Colombia

Medellín, Antioquia, 50021, Colombia
Medellin, Colombia

Medellín, 50016, Colombia
Milano, Italy

Milan, 20122, Italy
Milano, Italy

Milan, 20132, Italy
Milano, Italy

Milan, 20157, Italy
Minneapolis, MN

Minneapolis, Minnesota, 55435, United States
Mlada Boleslav, Czechia

Mladá Boleslav, 293 01, Czechia
Modesto, CA

Modesto, California, 95356, United States
Mountain View, CA

Mountain View, California, 94040, United States
Munchen, Germany

München, 80336, Germany
Munster, Germany

Münster, 48145, Germany
Nachod, Czechia

Náchod, 547 01, Czechia
Nashville, TN

Nashville, Tennessee, 37203, United States
Oceanside, NY

Oceanside, New York, 11572, United States
Olsztyn, Poland

Olsztyn, 10-424, Poland
Orlando, Florida

Orlando, Florida, 32806, United States
Osijek, Croatia

Osijek, 31000, Croatia
Paris, France

Paris, 75006, France
Paris, France

Paris, 75015, France
Paris, France

Paris, 75019, France
Parramatta, Australia

Parramatta, 2150, Australia
Pecs, Hungary

Pécs, H-7621, Hungary
Petah Tikva, Israel

Petah Tikva, 49100, Israel
Plano, TX

Plano, Texas, 75075, United States
Plantation, FL

Plantation, Florida, 33324, United States
Portland, Maine

Portland, Maine, 04101, United States
Portland, OR

Portland, Oregon, 97221, United States
Porto, Portugal

Porto, 4200-319, Portugal
Prague, Czechia

Prague, 1150/50, Czechia
Prague, Czechia

Prague, Czechia
Redlands, CA

Redlands, California, 92374, United States
Rehovot, Israel

Rehovot, 76100, Israel
Richmond, Virginia

Richmond, Virginia, 23235, United States
Riga, Latvia

Riga, LV1002, Latvia
Riga, Latvia

Riga, LV1006, Latvia
Rochester, NY

Rochester, New York, 14620, United States
Roma, Italy

Roma, 00168, Italy
Rome, Italy

Rome, 81.00133, Italy
Round Rock, TX

Round Rock, Texas, 78681, United States
Sacramento, CA

Sacramento, California, 95825, United States
Sacramento, CA

Sacramento, California, 95841, United States
Saint Cyr sur Loire, France

Saint-Cyr-sur-Loire, 37540, France
Saint Petersburg, FL

St. Petersburg, Florida, 33711, United States
Salt Lake City, Utah

Salt Lake City, Utah, 84107, United States
San Antonio, TX

San Antonio, Texas, 78240, United States
Santa Ana

Santa Ana, California, 92705, United States
Santa Fe, Argentina

Rosario, Santa Fe Province, S2000DSK, Argentina
Santa Fe, Argentina

Rosario, Sante Fe, 2000, Argentina
Santiago de Compostela, Spain

Santiago de Compostela, 15706, Spain
Sarasota, FL

Sarasota, Florida, 34232, United States
Schertz, Texas

Schertz, Texas, 78154, United States
Scottsdale

Scottsdale, Arizona, 85255, United States
Sevilla, Spain

Seville, 41009, Spain
Spokane, WA

Spokane, Washington, 99204, United States
Springdale, Arkansas

Springdale, Arkansas, 72764, United States
Springfield, Illinois

Springfield, Illinois, 62702, United States
Springfield, Oregon

Springfield, Oregon, 97477, United States
Springfield,MA

Springfield, Massachusetts, 01107, United States
Sunderland, United Kingdom

Sunderland, SR2 9HP, United Kingdom
Sydney Retina Clinic

Sydney, New South Wales, 2000, Australia
Sydney, Australia

Sydney, New South Wales, 2135, Australia
Sydney, Australia

Sydney, 2000, Australia
Szeged, Hungary

Szeged, H-6720, Hungary
Tallahassee, FL

Tallahassee, Florida, 32308, United States
Tampa, FL

Tampa, Florida, 33609-4614, United States
Tampa, FL

Tampa, Florida, 33617, United States
Tarnowskie Gory, Poland

Tarnowskie Góry, 42-600, Poland
Tel Aviv, Israel

Tel Aviv, 6423906, Israel
The Woodlands, TX

The Woodlands, Texas, 77384, United States
Trebisov, Slovakia

Trebišov, 075 01, Slovakia
Trencin, Slovakia

Trenčín, 911 01, Slovakia
Udine, Italy

Udine, 33100, Italy
Valencia, Spain

Burjassot, Valencia, 46100, Spain
Vienna, Austria

Vienna, 1090, Austria
Vienna, Austria

Vienna, 1140, Austria
Wake Forest, MC

Wake Forest, North Carolina, 27587, 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
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
Winter Haven, FL

Winter Haven, Florida, 33880, United States
Wolverhamptom, United Kingdom

Wolverhampton, WV10 0QP, United Kingdom
York, United Kingdom

York, UnitedKingdom, YO10 4DZ, United Kingdom
Youngstown, Ohio

Youngstown, Ohio, 44505, United States
Zalaegerszeg, Hungary

Zalaegerszeg, 8900, Hungary
Zaragoza, Spain

Zaragoza, 50009, Spain
Zilina, Slovakia

Žilina, 012 07, Slovakia

More trials for these conditions

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