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Diabetic Macular Edema (DME)Phase 2/3BAROLONCT06957080

A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME

A Phase 2/3 study testing Remigromig and Ranibizumab in people with Diabetic Macular Edema (DME), run by EyeBiotech Ltd. at 164 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
Remigromig and Ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,054 participants
Where
164 sitesin 6 countries
Study dates
16 Apr 2025to 30 Mar 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

164 sites in 6 countries.

164 sites in 6 countries

United States107 sites

  • Abilene, TX

    Abilene, Texas, 79606

  • Aiken, SC

    Aiken, South Carolina, 29802

  • Albuquerque, New Mexico

    Albuquerque, New Mexico, 87109

  • Amarillo, TX

    Amarillo, Texas, 79106

  • Arlington, TX

    Arlington, Texas, 76012

  • Asheville, NC

    Asheville, North Carolina, 28803

  • Austin, TX

    Austin, Texas, 78705

  • Bakersfield, CA

    Bakersfield, California, 93309

  • Baltimore, Maryland

    Baltimore, Maryland, 21209

  • Beaufort, NC

    Beaufort, South Carolina, 29902

  • Beaufort, SC

    Beaufort, South Carolina, 29902

  • Bellaire, TX

    Bellaire, Texas, 77401

  • Bellevue, Washington

    Bellevue, Washington, 98004

  • Bethlehem, PA

    Bethlehem, Pennsylvania, 18017

  • Bloomfield, NJ

    Bloomfield, New Jersey, 07003

  • Bluffton, NC

    Bluffton, South Carolina, 29910

  • Burleson, Texas

    Burleson, Texas, 76028

  • Burlington, Washington

    Burlington, Washington, 98233

  • Cary, North Carolina

    Cary, North Carolina, 27511

  • Charleston, SC

    Charleston, South Carolina, 29414

  • Cherry Hill, NJ

    Cherry Hill, New Jersey, 08034

  • Colorado Springs, CO

    Colorado Springs, Colorado, 80909

  • Dallas, TX

    Dallas, Texas, 75231

  • Danbury, CT

    Danbury, Connecticut, 06810

  • Deerfield Beach, FL

    Deerfield Beach, Florida, 33064

  • Denver, CO

    Denver, Colorado, 80012

  • Durango, CO

    Durango, Colorado, 81303

  • Edina, MN

    Edina, Minnesota, 55435

  • Encino, California

    Encino, California, 91436

  • Erie, PA

    Erie, Pennsylvania, 16507

  • Fayetteville, AR

    Fayetteville, Arkansas, 72703

  • Florence, SC

    Florence, South Carolina, 29501

  • Fort Lauderdale, FL

    Fort Lauderdale, Florida, 33308

  • Fort Myers, FL

    Fort Myers, Florida, 33912

  • Fort Worth, TX

    Fort Worth, Texas, 76104

  • Gainesville, FL

    Gainesville, Florida, 32607

  • Germantown, TN

    Germantown, Tennessee, 38138

  • Gilbert, Arizona

    Gilbert, Arizona, 85297

  • Grand Rapids, MI

    Grand Rapids, Michigan, 49546

  • Great Neck, New York

    Great Neck, New York, 11021

  • Hagerstown, MD

    Hagerstown, Maryland, 21740

  • Hauppauge, New York

    Hauppauge, New York, 11788

  • Henderson, Nevada

    Henderson, Nevada, 89052

  • Hickory, NC

    Hickory, North Carolina, 28602

  • Hixson, TN

    Hixson, Tennessee, 37343

  • Johnson City, TN

    Johnson City, Tennessee, 37604

  • Joliet, Illinois

    Joliet, Illinois, 60435

  • Katy, TX

    Katy, Texas, 77494

  • Knoxville, TN

    Knoxville, Tennessee, 37922

  • Ladson, NC

    Ladson, South Carolina, 29456

  • Ladson, SC

    Ladson, South Carolina, 29456

  • Lemont, IL

    Lemont, Illinois, 60439

  • Lenexa, KS

    Lenexa, Kansas, 66215

  • Liverpool, NY

    Liverpool, New York, 13088

  • Lynchburg, VA

    Lynchburg, Virginia, 24502

  • Madison, MS

    Madison, Mississippi, 39110

  • Manchester, CT

    Manchester, Connecticut, 06042

  • Minneapolis, MN

    Minneapolis, Minnesota, 55435

  • Modesto, CA

    Modesto, California, 95356

  • Mountain View, CA

    Mountain View, California, 94040

  • Nashville, TN

    Nashville, Tennessee, 37203

  • New York, NY

    New York, New York, 10022

  • Oak Park, IL

    Oak Park, Illinois, 60304

  • Orlando, FL

    Orlando, Florida, 32806

  • Phoenix, Arizona

    Phoenix, Arizona, 85020

  • Plano, TX

    Plano, Texas, 75075

  • Plantation, FL

    Plantation, Florida, 33324

  • Portland, ME

    Portland, Maine, 04101

  • Portland, OR

    Portland, Oregon, 97221

  • Portland, Oregon

    Portland, Oregon, 97225

  • Redlands, CA

    Redlands, California, 92374

  • Richmond, VA

    Richmond, Virginia, 23235

  • Rochester, NY

    Rochester, New York, 14620

  • Round Rock, TX

    Round Rock, Texas, 78681

  • Sacramento, CA

    Sacramento, California, 95825

  • Sacramento, CA

    Sacramento, California, 95841

  • Salem, Oregon

    Salem, Oregon, 97302

  • Salt Lake City, UT

    Salt Lake City, Utah, 84107

  • San Antonio, TX

    San Antonio, Texas, 78240

  • San Marcos, Texas

    San Marcos, Texas, 78666

  • Santa Ana, CA

    Santa Ana, California, 92705

  • Santa Ana

    Santa Ana, California, 92705

  • Sarasota, FL

    Sarasota, Florida, 34232

  • Schertz, TX

    Schertz, Texas, 78154

  • Scottsdale, AZ

    Scottsdale, Arizona, 85255

  • Spokane, WA

    Spokane, Washington, 99204

  • Springfield, IL

    Springfield, Illinois, 62702

  • Springfield,MA

    Springfield, Massachusetts, 01107

  • Springfield, OR

    Springfield, Oregon, 97477

  • Saint Petersburg, FL

    St. Petersburg, Florida, 33711

  • Tallahassee, FL

    Tallahassee, Florida, 32308

  • Tampa, FL

    Tampa, Florida, 33609

  • Tampa, FL

    Tampa, Florida, 33617

  • The Woodlands, TX

    The Woodlands, Texas, 77384

  • Towson, MD

    Towson, Maryland, 21204

  • Tulsa, Oklahoma

    Tulsa, Oklahoma, 74114

  • Wake Forest, NC

    Wake Forest, North Carolina, 27587

  • Waterford, CT

    Waterford, Connecticut, 06385

  • Waterford,CT

    Waterford, Connecticut, 06385

  • West Columbia, SC

    West Columbia, South Carolina, 29169

  • West Des Moines, IA

    West Des Moines, Iowa, 50266

  • West Jordan, Utah

    West Jordan, Utah, 84088

  • Wichita, Kansas

    Wichita, Kansas, 67214

  • Willow Park, TX

    Willow Park, Texas, 76087

  • Winston Salem, NC

    Winston-Salem, North Carolina, 27103

  • Winston-Salem, NC

    Winston-Salem, North Carolina, 27103

  • Winter Haven, FL

    Winter Haven, Florida, 33880

Other trials in United States

Japan26 sites

  • Amagasaki, Japan

    Amagasaki, Hyōgo, 660-8550

  • Asahikawa, Japan

    Asahikawa, Hokkaido, 078-8510

  • Fukuoka-shi, Japan

    Fukuoka, Fukuoka, 812-0011

  • Fukuoka-shi, Japan

    Fukuoka, Higashi-ku Fukuoka, 811-0213

  • Fukushima, Japan

    Fukushima, 960-1295

  • Hachioji, Japan

    Hachiōji, Tokyo, 193-0998

  • Hirosaki, Japan

    Hirosaki, Aomori, 036-8563

  • Kagoshima City, Japan

    Kagoshima, Kagoshima-ken, 890-8520

  • Kita-gun, Japan

    Kita-gun, Kagawa-ken, 761-0793

  • Kurume City, Japan

    Kurume, Fukuoka, 830-8543

  • Meguro-ku, Japan

    Meguro-ku, Tokyo, 152-8902

  • Mito, Japan

    Mito, Ibaraki, 310-0845

  • Miyazaki, Japan

    Miyazaki, 889-1692

  • Nagoya City, Japan

    Nagoya, Aichi-ken, 466-8560

  • Osaka, Japan

    Osaka, 530-8480

  • Osaka, Japan

    Osaka, 540-0006

  • Osaka, Japan

    Osaka, 545-8586

  • Sakura, Japan

    Sakura, Chiba, 285-8741

  • Shimotsuke-shi, Japan

    Shimotsuke-shi, Tochigi, 329-0498

  • Taito-ku, Japan

    Taito-ku, Tokyo, 111-0051

  • Tokorozawa-shi, Japan

    Tokorozawa-shi, Saitama, 359-8513

  • Tokushima, Japan

    Tokushima, 770-8503

  • Tokyo, Japan

    Tokyo, 101-8309

  • Ube-shi, Japan

    Ube-shi, Yamaguchi, 755-8505

  • Yamagata, Japan

    Yamagata, 990-9585

  • Yoshida-gun, Japan

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

Argentina14 sites

  • Buenos Aires, Argentina

    Buenos Aires, 1015

  • Buenos Aires, Argentina

    Buenos Aires, 1023

  • Buenos Aires, Argentina

    Buenos Aires, 1120

  • Buenos Aires, Argentina

    Buenos Aires, B18321XE

  • Buenos Aires, Argentina

    Buenos Aires, B1878KDF

  • Buenos Aires, Argentina

    Buenos Aires, C1008

  • Buenos Aires, Argentina

    Buenos Aires, C1033AAW

  • Buenos Aires, Argentina

    Buenos Aires, C1116ABA

  • Buenos Aires, Argentina

    Buenos Aires, C1280AEB

  • Cordoba, Argentina

    Córdoba, X5000AAJ

  • Cordoba, Argentina

    Córdoba, X5000

  • Salta, Argentina

    Salta, 4400

  • Salta, Argentina

    Salta, A4400

  • Santa Fe, Argentina

    Santa Fe, S2000

Other trials in Argentina

Brazil10 sites

  • Aparecida De Goiania, Brazil

    Aparecida de Goiânia, 74210-010

  • Aparecida de Goiania, Brazil

    Aparecida de Goiânia, 74980-010

  • Assis, Brazil

    Assis, 19814-470

  • Belo Horizonte, Brazil

    Belo Horizonte, 30330-000

  • Blumenau, Brazil

    Blumenau, 89010-204

  • Porto Alegre, Brazil

    Porto Alegre, 90.440-051

  • Sao Paulo, Brazil

    São Paulo, 04023-062

  • Sao Paulo, Brazil

    São Paulo, 04038-032

  • Sorocaba, Brazil

    Sorocaba, 18031-060

  • Vitoria, Brazil

    Vitória, 29055-450

Other trials in Brazil

Colombia5 sites

  • Barranquilla, Colombia

    Barranquilla, 080001

  • Bogata, Colombia

    Bogotá, 110231

  • Cali, Colombia

    Cali, 760042

  • Medelin, Colombia

    Medellín, 050021

  • Medellin, Colombia

    Medellín, 50021

Other trials in Colombia

Puerto Rico2 sites

  • Arecibo, PR

    Arecibo, 00612

  • San Juan, Puerto Rico

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: 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

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (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 remigromig 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.

Read the detailed description

EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig 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 remigromig, high dose remigromig, 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 remigromig 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 Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Being tested
Remigromig, Ranibizumab
Keywords
Diabetic Macular Edema, DME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemigromigDrug

    Also called EYE103, Restoret

    Remigromig is a humanized antibody formulated for intravitreal administration

  • RanibizumabDrug

    Also called Lucentis

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

Study groups in NCT06957080
Study groupRoleWhat they receive
Remigromig Low Dose Treatment ArmExperimentalRemigromig Low Dose Treatment Arm
Receives: Drug: Remigromig
Remigromig High Dose Treatment ArmExperimentalRemigromig High Dose Treatment Arm
Receives: Drug: Remigromig
Ranibizumab Treatment ArmActive comparatorRanibizumab Treatment Arm
Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

    The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.

    Measured: Baseline and Week 52

Secondary outcomes (11)

  1. Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52

    The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented.

    Measured: Baseline and Week 52

  2. Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52

    The Superiority Hypothesis: change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

    Measured: Baseline and Week 52

  3. Time to Absence of Diabetic Macular Edema (DME)

    The time to absence of Diabetic Macular Edema (DME) defined as Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) of <300 μm will be presented.

    Measured: Up to approximately Week 52

  4. Time to Gaining ≥15 ETDRS Letters

    The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.

    Measured: Up to approximately Week 52

  5. Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24

    The proportion of participants with resolution of macular leakage on fluorescein angiography (FA), defined as 0 to 1 mm^2, at Week 24 will be presented.

    Measured: Up to approximately Week 24

  6. Proportion of Participants without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52

    The proportion of participants without intraretinal and subretinal fluid at the foveal center on Optical Coherence Tomography (OCT) at Week 52 will be presented.

    Measured: Up to approximately Week 52

  7. Change from Baseline in Focal Area Zone (FAZ) area on Fluorescein Angiography (FA) at Week 52

    The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented.

    Measured: Baseline and Week 52

  8. Proportion of Participants Achieving 20/40 or Better BCVA at Week 52

    The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.

    Measured: Up to approximately Week 52

  9. Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic AE will be reported.

    Measured: Up to approximately 104 Weeks

  10. Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic serious adverse event (SAE) will be reported.

    Measured: Up to approximately 104 Weeks

  11. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 104 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start16 Apr 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel enrollment into 1 of 3 arms
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,054 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957080
Sponsor's protocol ID
EYE-RES-103
Other IDs
MK-3000-002, 2025-520809-12-00, jRCT2071250032, 2025
Acronym
BAROLO
Status last verified
Oct 2026
First submitted
16 Apr 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Remigromig and Ranibizumab in people with Diabetic Macular Edema (DME), run by EyeBiotech Ltd. at 164 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, Japan, Argentina, Brazil, Colombia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06957080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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