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

NCT06571045 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EYE-RES-102
• Study Type: interventional
• Target: 984
• Locations: 19 countries
• Sites: 178

Brief 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.

Conditions

Diabetic Macular Edema (DME)

Keywords

Diabetic Macular Edema; DME

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 (1)

• Changes in structural and visual outcomes

  Duration of the study, through Week 104

Study Arms (3)

EYE103 Low Dose Treatment Arm

EXPERIMENTAL

EYE103 Low Dose Treatment Arm

Drug: EYE103

EYE103 High Dose Treatment Arm

EXPERIMENTAL

EYE103 High Dose Treatment Arm

Drug: EYE103

Ranibizumab Treatment Arm

ACTIVE COMPARATOR

Ranibizumab Treatment Arm

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

Also known as: Lucentis

Ranibizumab Treatment Arm

EYE103 DRUG

EYE103 is a humanized antibody formulated for intravitreal administration

Also known as: Restoret

EYE103 High Dose Treatment Arm; EYE103 Low Dose Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• EyeBiotech Ltd.: lead

Study Sites (183)

Scottsdale

Scottsdale, Arizona, 85255, United States

Location

Fayetteville, Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Springdale, Arkansas

Springdale, Arkansas, 72764, United States

Location

Bakersfield, CA

Bakersfield, California, 93309, United States

Location

Glendale, CA

Glendale, California, 91204, United States

Location

Modesto, CA

Modesto, California, 95356, United States

Location

Mountain View, CA

Mountain View, California, 94040, United States

Location

Redlands, CA

Redlands, California, 92374, United States

Location

Sacramento, CA

Sacramento, California, 95825, United States

Location

Sacramento, CA

Sacramento, California, 95841, United States

Location

Santa Ana

Santa Ana, California, 92705, United States

Location

Colorado Springs, CO

Colorado Springs, Colorado, 80909, United States

Location

Denver, Colorado

Denver, Colorado, 80210, United States

Location

Danbury, CT

Danbury, Connecticut, 06810, United States

Location

Manchester, CT

Manchester, Connecticut, 06042, United States

Location

Waterford,CT

Waterford, Connecticut, 06385, United States

Location

Deerfield Beach, FL

Deerfield Beach, Florida, 33064, United States

Location

Fort Lauderdale, FL

Fort Lauderdale, Florida, 33308, United States

Location

Fort Myers,FL

Fort Myers, Florida, 33912, United States

Location

Gainesville, FL

Gainesville, Florida, 32607, United States

Location

Orlando, Florida

Orlando, Florida, 32806, United States

Location

Plantation, FL

Plantation, Florida, 33324, United States

Location

Sarasota, FL

Sarasota, Florida, 34232, United States

Location

Saint Petersburg, FL

St. Petersburg, Florida, 33711, United States

Location

Tallahassee, FL

Tallahassee, Florida, 32308, United States

Location

Tampa, FL

Tampa, Florida, 33609-4614, United States

Location

Tampa, FL

Tampa, Florida, 33617, United States

Location

Winter Haven, FL

Winter Haven, Florida, 33880, United States

Location

Lemont, IL

Lemont, Illinois, 60439, United States

Location

Springfield, Illinois

Springfield, Illinois, 62702, United States

Location

West Des Moines, IA

West Des Moines, Iowa, 50266, United States

Location

Lenexa, Kansas

Lenexa, Kansas, 66215, United States

Location

Wichita, Kansas

Wichita, Kansas, 67214, United States

Location

Portland, Maine

Portland, Maine, 04101, United States

Location

Hagerstown, MD

Hagerstown, Maryland, 21740, United States

Location

Springfield,MA

Springfield, Massachusetts, 01107, United States

Location

Grand Rapids, Michigan

Grand Rapids, Michigan, 49546, United States

Location

Minneapolis, MN

Minneapolis, Minnesota, 55435, United States

Location

Madison, MS

Madison, Mississippi, 39110, United States

Location

Bloomfield, NJ

Bloomfield, New Jersey, 07003, United States

Location

Cherry Hill, NJ

Cherry Hill, New Jersey, 08034, United States

Location

Liverpool, NY

Liverpool, New York, 13088, United States

Location

Oceanside, NY

Oceanside, New York, 11572, United States

Location

Rochester, NY

Rochester, New York, 14620, United States

Location

Asheville, NC

Asheville, North Carolina, 28803, United States

Location

Hickory, NC

Hickory, North Carolina, 28602, United States

Location

Wake Forest, MC

Wake Forest, North Carolina, 27587, United States

Location

Winston Salem, NC

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland, Ohio

Cleveland, Ohio, 44122, United States

Location

Cleveland, OH

Cleveland, Ohio, 44130, United States

Location

Youngstown, Ohio

Youngstown, Ohio, 44505, United States

Location

Edmond, OK

Edmond, Oklahoma, 73013, United States

Location

Portland, OR

Portland, Oregon, 97221, United States

Location

Springfield, Oregon

Springfield, Oregon, 97477, United States

Location

Bethlehem, PA

Bethlehem, Pennsylvania, 18017, United States

Location

Erie, PA

Erie, Pennsylvania, 16507, United States

Location

Beaufort, SC

Beaufort, South Carolina, 29902, United States

Location

Florence, SC

Florence, South Carolina, 29501, United States

Location

Ladson, SC

Ladson, South Carolina, 29456, United States

Location

West Columbia, SC

West Columbia, South Carolina, 29169, United States

Location

Germantown, TN

Germantown, Tennessee, 38138, United States

Location

Hixson, Tennessee

Hixson, Tennessee, 37343, United States

Location

Johnson City, Tennessee

Johnson City, Tennessee, 37604, United States

Location

Knoxville, TN

Knoxville, Tennessee, 37922, United States

Location

Nashville, TN

Nashville, Tennessee, 37203, United States

Location

Abilene, TX

Abilene, Texas, 79606, United States

Location

Amarillo, TX

Amarillo, Texas, 79106, United States

Location

Amarillo, TX

Amarillo, Texas, 79109, United States

Location

Arlington, TX

Arlington, Texas, 76012, United States

Location

Austin, TX

Austin, Texas, 78705, United States

Location

Beaumont, TX

Beaumont, Texas, 77707, United States

Location

Bellaire, TX

Bellaire, Texas, 77401, United States

Location

Dallas, TX

Dallas, Texas, 75231, United States

Location

Fort Worth, TX

Fort Worth, Texas, 76104, United States

Location

Katy, TX

Katy, Texas, 77494, United States

Location

Plano, TX

Plano, Texas, 75075, United States

Location

Round Rock, TX

Round Rock, Texas, 78681, United States

Location

San Antonio, TX

San Antonio, Texas, 78240, United States

Location

Schertz, Texas

Schertz, Texas, 78154, United States

Location

The Woodlands, TX

The Woodlands, Texas, 77384, United States

Location

Willow Park, TX

Willow Park, Texas, 76087, United States

Location

Salt Lake City, Utah

Salt Lake City, Utah, 84107, United States

Location

Lynchburg, VA

Lynchburg, Virginia, 24502, United States

Location

Richmond, Virginia

Richmond, Virginia, 23235, United States

Location

Spokane, WA

Spokane, Washington, 99204, United States

Location

Ciudad de Cordoba, Argentina

Córdoba, Argentina, X5000AAJ, Argentina

Location

Buenos Aires, Argentina

CABA, Buenos Aires, 1015, Argentina

Location

Buenos Aires, Argentina

CABA, Buenos Aires, 1120, Argentina

Location

Buenos Aires, Argentina

CABA, Buenos Aires, C1033AAW, Argentina

Location

Caba, Buenos Aires, Argentina

Caba, Buenos Aires, C1116ABA, Argentina

Location

Cordoba, Argentina

Córdoba, Córdoba Province, 5000, Argentina

Location

Santa Fe, Argentina

Rosario, Santa Fe Province, S2000DSK, Argentina

Location

Santa Fe, Argentina

Rosario, Sante Fe, 2000, Argentina

Location

Buenos Aires, Argentina

CABA, 1023, Argentina

Location

Albury, Australia

Albury, Australia, 2640, Australia

Location

Parramatta, Australia

Parramatta, Australia, 2150, Australia

Location

Sydney, Australia

Sydney, Australia, 2000, Australia

Location

Sydney Retina Clinic

Sydney, New South Wales, 2000, Australia

Location

Sydney, Australia

Sydney, New South Wales, 2135, Australia

Location

Innsbruck, Austria

Innsbruck, Austria, 6020, Austria

Location

Vienna, Austria

Vienna, Vienna, 1090, Austria

Location

Graz, Austria

Graz, 8036, Austria

Location

Vienna, Austria

Vienna, 1140, Austria

Location

Medellin, Colombia

Medellín, Antioquia, 50021, Colombia

Location

Barranquilla, Colombia

Barranquilla, Atlántico, 80002, Colombia

Location

Medellin, Colombia

Medellín, Colombia, 50016, Colombia

Location

Bogota, Columbia

Bogotá, Columbia, 110231, Colombia

Location

Cali, Colombia

Cali, Valle del Cauca Department, 760042, Colombia

Location

Osijek, Croatia

Osijek, 31000, Croatia

Location

Prague, Czechia

Prague, Prague, 1150/50, Czechia

Location

Mlada Boleslav, Czechia

Mladá Boleslav, 293 01, Czechia

Location

Nachod, Czechia

Náchod, 547 01, Czechia

Location

Prague, Czechia

Prague, Czechia

Location

Cedex, France

Dijon, Cedex, 21079, France

Location

Lyon, France

Lyon, France, 69004, France

Location

Paris, France

Paris, Paris, 75019, France

Location

Creteil, France

Créteil, 94010, France

Location

Marseille, France

Marseille, 13008, France

Location

Paris, France

Paris, 75006, France

Location

Paris, France

Paris, 75015, France

Location

Saint Cyr sur Loire, France

Saint-Cyr-sur-Loire, 37540, France

Location

Frankfurt, Germany

Frankfurt, Germany, 60590, Germany

Location

Hanover, Germany

Hanover, Germany, 30625, Germany

Location

Munchen, Germany

München, Germany, 80336, Germany

Location

Munster, Germany

Münster, Germany, 48145, Germany

Location

Budapest, Hungary

Budapest, Budapest, H-1085, Hungary

Location

Budapest, Hungary

Budapest, Hungary, H-1062, Hungary

Location

Budapest, Hungary

Budapest, Hungary, H-1106, Hungary

Location

Debrecen, Hungary

Debrecen, Hungary, H-4032, Hungary

Location

Zalaegerszeg, Hungary

Zalaegerszeg, Hungary, 8900, Hungary

Location

Budapest, Hungry

Budapest, H-1133, Hungary

Location

Pecs, Hungary

Pécs, H-7621, Hungary

Location

Szeged, Hungary

Szeged, H-6720, Hungary

Location

Rehovot, Israel

Rehovot, Israel, 76100, Israel

Location

Beer Yakov, Israel

Be’er Ya‘aqov, 70300, Israel

Location

Haifa, Israel

Haifa, 3436212, Israel

Location

Jerusalem, Israel

Jerusalem, 9112001, Israel

Location

Petah Tikva, Israel

Petah Tikva, 49100, Israel

Location

Tel Aviv, Israel

Tel Aviv, 6423906, Israel

Location

Bologna, Italy

Bologna, Italy, 40138, Italy

Location

Milano, Italy

Milan, Italy, 20157, Italy

Location

Roma, Italy

Roma, Italy, 00168, Italy

Location

Udine, Italy

Udine, Italy, 33100, Italy

Location

Milano, Italy

Milan, Milano, 20132, Italy

Location

Rome, Italy

Rome, Rome, 81.00133, Italy

Location

Firenze, Italy

Florence, 50139, Italy

Location

Milano, Italy

Milan, 20122, Italy

Location

Riga, Latvia

Riga, Rīga, LV1002, Latvia

Location

Riga, Latvia

Riga, Rīga, LV1006, Latvia

Location

Gdansk, Poland

Gdansk, Gdansk, 80-809, Poland

Location

Bialystok, Poland

Bialystok, Poland, 15-866, Poland

Location

Bydgoszcz, Poland

Bydgoszcz, Poland, 85-309, Poland

Location

Katowice, Poland

Katowice, Poland, 40-594, Poland

Location

Krakow, Poland

Krakow, Poland, 31-501, Poland

Location

Tarnowskie Gory, Poland

Tarnowskie Góry, Poland, 42-600, Poland

Location

Bydgoszcz, Poland

Bydgoszcz, 85-631, Poland

Location

Gdansk, Poland

Gdansk, 80-809, Poland

Location

Olsztyn, Poland

Olsztyn, 10-424, Poland

Location

Porto, Portugal

Porto, Porto District, 4200-319, Portugal

Location

Coimbra, Portugal

Coimbra, 3000-548, Portugal

Location

Coimbra, Portugal

Coimbra, 3030-163, Portugal

Location

Arecibo, PR

Arecibo, PR, 00612, Puerto Rico

Location

Trebisov, Slovakia

Trebišov, Slovakia, 075 01, Slovakia

Location

Trencin, Slovakia

Trenčín, Slovakia, 911 01, Slovakia

Location

Zilina, Slovakia

Žilina, Slovakia, 012 07, Slovakia

Location

Barcelona, Spain

Barcelona, Barcelona, 08195, Spain

Location

Sevilla, Spain

Seville, Sevilla, 41009, Spain

Location

Barcelona, Spain

Barcelona, Spain, 08021, Spain

Location

Barcelona, Spain

Barcelona, Spain, 08035, Spain

Location

Santiago de Compostela, Spain

Santiago de Compostela, Spain, 15706, Spain

Location

Zaragoza, Spain

Zaragoza, Spain, 50009, Spain

Location

Valencia, Spain

Burjassot, Valencia, 46100, Spain

Location

Barcelona, Spain

Barcelona, 08022, Spain

Location

Ankara, Turkey

Ankara, Turkey, 06230, Turkey (Türkiye)

Location

Ankara, Turkey

Ankara, Turkey, 06490, Turkey (Türkiye)

Location

Balcova, Turkey

Balçova, Turkey, 35330, Turkey (Türkiye)

Location

London, UK

London, Middlesex, NW10 7NS, United Kingdom

Location

Bradford, United Kingdom

Bradford, United Kingdom, BD9 6RJ, United Kingdom

Location

Liverpool, United Kingdom

Liverpool, United Kingdom, L7 8YA, United Kingdom

Location

Sunderland, United Kingdom

Sunderland, United Kingdom, SR2 9HP, United Kingdom

Location

Wolverhamptom, United Kingdom

Wolverhampton, United Kingdom, WV10 0QP, United Kingdom

Location

York, United Kingdom

York, UnitedKingdom, YO10 4DZ, United Kingdom

Location

Bristol, UK

Bristol, BS1 2LX, United Kingdom

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Charles Miller, MD PhD

  EyeBiotech Ltd.

  STUDY DIRECTOR

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

Model Details: Parallel enrollment into 1 of 3 arms

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 26, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (4); FR (8); IL (6); SL (3); US (85); PL (9); ES (8); CO (5); HU (8); CR (1); LA (2); PT (3); IT (8); AR (9); PR (1); TU (3); DE (4); AU (4); GB (7)