Neovascular Age-Related Macular Degeneration (NVAMD)Phase 2Super TuscanNCT07205887

A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO

A Phase 2 study testing Remigromig and Aflibercept 2.0 mg in people with Neovascular Age-Related Macular Degeneration (NVAMD) and Branch Retinal Vein Occlusion (BRVO), run by EyeBiotech Ltd. at 55 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

EYE-RES-104 is a randomized, dose-masked study of intravitreal remigromig (EYE103) in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
What is being tested?: Remigromig and Aflibercept 2.0 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 55 sitesUnited States
Study dates: 12 Sep 2025to 30 Jun 2028
Phase: Phase 2

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

Key General 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
Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria
Be ≥ 50 years of age
Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement
For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment

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Key Incomplete Responder (IR) NVAMD-specific Inclusion Criteria
Be ≥ 50 years of age
Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2
Key Branch Retinal Vein Occlusion (BRVO)-specific Inclusion Criteria
Be diagnosed with BRVO in the study eye
Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO
Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening

Who cannot join

Key General Exclusion Criteria
Pregnant or breastfeeding
History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
Currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
Key NVAMD-specific Exclusion Criteria

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Have had previous thermal subfoveal laser therapy in the study eye
Have had previous photodynamic therapy with Visudyne in the study eye
Key BRVO-specific Exclusion Criteria
Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, diabetic macular edema, NVAMD, Irvine-Gass syndrome)
Have active iris or angle neovascularization or neovascular glaucoma in the study eye

Trial locations and contacts

55 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Charles Miller, MD PhD contact

212-914-0127

ClinicalInquiries@eyebiotech.com

City, postcode or hospital

Sites recruiting now only

55 sites in 1 country

United States55 sites, 55 recruiting

Abilene, Texas
Abilene, Texas, 79606
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Amarillo, Texas
Amarillo, Texas, 79106
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Asheville, North Carolina
Asheville, North Carolina, 28803
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Austin, Texas
Austin, Texas, 78705
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Austin, TX
Austin, Texas, 78705
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Bellaire, Texas
Bellaire, Texas, 77401
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Bellaire, TX
Bellaire, Texas, 77401
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Bloomfield, New Jersey
Bloomfield, New Jersey, 07003
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Bloomfield, NJ
Bloomfield, New Jersey, 07003
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Burleson, Texas
Burleson, Texas, 76028
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Cary, North Carolina
Cary, North Carolina, 27511
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Retina Consultants, PLLC
Charleston, West Virginia, 25301
Study Coordinator, 304-346-4400
Recruiting
Dallas, Texas
Dallas, Texas, 75231
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Dallas, TX
Dallas, Texas, 75231
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
RSC Research LLC
Denver, Colorado, 80222
Study Coordinator, 720-443-2425
Recruiting
Fort Lauderdale, Florida
Fort Lauderdale, Florida, 33308
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Fort Lauderdale, FL
Fort Lauderdale, Florida, 33308
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Germantown, Tennessee
Germantown, Tennessee, 38138
Charles Miller, MD PhD, ClinicalInquiries@eyebiotech.com
Recruiting
Glendale, California
Glendale, California, 91204
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Glendale, CA
Glendale, California, 91204
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Long Island Vitreoretinal Consultants of NY
Great Neck, New York, 11021
Study Coordinator, 516-466-0390
Recruiting
North Carolina Retina Associates
Greenville, North Carolina, 27834
Study Coordinator, 919-782-8038
Recruiting
Hagerstown, Maryland
Hagerstown, Maryland, 21740
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Hagerstown, MD
Hagerstown, Maryland, 21740
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Florida Retina Institute
Jacksonville, Florida, 32216
Study Coordinator, 904-997-9202
Recruiting
Knoxville, Tennessee
Knoxville, Tennessee, 37922
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Lemont, Illinois
Lemont, Illinois, 60439
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Lemont, IL
Lemont, Illinois, 60439
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Madison, Mississippi
Madison, Mississippi, 39110
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Madison, MS
Madison, Mississippi, 39110
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Modesto, California
Modesto, California, 95356
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Mountain View, California
Mountain View, California, 94040
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Nashville, Tennessee
Nashville, Tennessee, 37203
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Nashville, TN
Nashville, Tennessee, 37203
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Florida Retina Institute
Orlando, Florida, 32806
Study Coordinator, 407-849-9621
Recruiting
Plano, Texas
Plano, Texas, 75075
Charles Miller, MD PhD, ClinicalInquiries@eyebiotech.com
Recruiting
Round Rock, TX
Round Rock, Texas, 78681
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Round Rock, Texas
Round Rock, Texas, 78781
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Sacramento, CA
Sacramento, California, 95825
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Sactamento, California
Sacramento, California, 95825
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Sacramento, California
Sacramento, California, 95841
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
San Antonio, Texas
San Antonio, Texas, 78240
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
San Antonio, TX
San Antonio, Texas, 78240
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
San Marcos, Texas
San Marcos, Texas, 78666
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Santa Ana, California
Santa Ana, California, 92705
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Scottsdale, Arizona
Scottsdale, Arizona, 85255
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Scottsdale, AZ
Scottsdale, Arizona, 85255
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
The Woodlands, Texas
The Woodlands, Texas, 77384
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
The Woodlands, TX
The Woodlands, Texas, 77384
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Wake Forest, NC
Wake Forest, North Carolina, 27587
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Wake Forest, North Carolina
Wake Forest, North Carolina, 27587
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
West Columbia, SC
West Columbia, South Carolina, 29169
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
West Columbia, South Carolina
West Columbia, South Carolina, 29169
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
West Jordan, Utah
West Jordan, Utah, 84088
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting
Willow Park, Texas
Willow Park, Texas, 76087
Charles Miller, MD PhD, 212-914-0127, ClinicalInquiries@eyebiotech.com
Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Dose-Masked Study of Intravitreal EYE103 in Participants With Neovascular Age-Related Macular Degeneration (NVAMD) or Macular Edema Following Branch Retinal Vein Occlusion (BRVO)

The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of remigromig via IVT or a high dose of remigromig via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.

All participants in the study will receive a total of 3 injections of remigromig into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.

Read the detailed description

EYE-RES-104 is a randomized, dose-masked study of intravitreal remigromig in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).

The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of remigromig via IVT or a high dose of remigromig via IVT:

one cohort of 40 treatment naïve NVAMD participants will be randomized (1:1) to 1 of the 2 doses of remigromig (as monotherapy),
one cohort of 40 incomplete responder (IR) NVAMD participants will be randomized (1:1) to 1 of the 2 doses of remigromig (as monotherapy),
one cohort of 40 IR NVAMD participants will be randomized (1:1) to 1 of the 2 doses of remigromig, to be administered in combination with aflibercept 2.0 mg
one cohort of 40 treatment naïve BRVO participants will be randomized (1:1) to 1 of the 2 doses of remigromig (as monotherapy)

Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.

All participants in the study will receive a total of 3 injections of remigromig into the study eye, spaced at 4 weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg in the study eye on Day 1.

All participants will be assessed for safety and efficacy at injection visits. Treatment naïve NVAMD participants and IR NVAMD participants in the monotherapy cohort will also return 2 weeks after each injection visit for safety and efficacy assessments. Depending on the cohort, participants will be evaluated every 2 weeks or every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns. The Week 12 Visit will serve as the end of study visit for all participants.

Conditions: Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
Being tested: Remigromig, Aflibercept 2.0 mg
Keywords: Neovascular Age-Related Macular Degeneration, Branch Retinal Vein Occlusion, NVAMD, BRVO
Medical subject headings: Retinal Vein Occlusion

What participants receive

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

RemigromigDrug
Also called Restoret, EYE103
Remigromig is a humanized antibody formulated for intravitreal administration
Aflibercept 2.0 mgDrug
Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose Remigromig.

Study groups in NCT07205887
Study group	Role	What they receive
Treatment Naïve NVAMD - Low Dose Remigromig	Experimental	Treatment Naïve NVAMD Cohort - Low Dose Remigromig (50 μL) Receives: Drug: Remigromig
Treatment Naïve NVAMD - High Dose Remigromig	Experimental	Treatment Naïve NVAMD Cohort - High Dose Remigromig (50 μL) Receives: Drug: Remigromig
IR NVAMD - Low Dose Remigromig	Experimental	Incomplete Responder (IR) NVAMD Cohort - Low Dose Remigromig (50 μL) Receives: Drug: Remigromig
IR NVAMD - High Dose Remigromig	Experimental	Incomplete Responder (IR) NVAMD Cohort - High Dose Remigromig (50 μL) Receives: Drug: Remigromig
IR NVAMD - Low Dose Remigromig in combination with Aflibercept 2.0 mg	Experimental	Incomplete Responder (IR) NVAMD Cohort - Low Dose Remigromig (50 μL) in combination with Aflibercept 2.0 mg Receives: Drug: Remigromig; Drug: Aflibercept 2.0 mg
IR NVAMD - High Dose Remigromig in combination with Aflibercept 2.0 mg	Experimental	Incomplete Responder (IR) NVAMD Cohort - High Dose Remigromig (50 μL) in combination with Aflibercept 2.0 mg Receives: Drug: Remigromig; Drug: Aflibercept 2.0 mg
Treatment Naïve BRVO - Low Dose Remigromig	Experimental	Treatment Naïve BRVO Cohort - Low Dose Remigromig (50 μL) Receives: Drug: Remigromig
Treatment Naïve BRVO - High Dose Remigromig	Experimental	Treatment Naïve BRVO Cohort - High Dose Remigromig (50 μL) Receives: Drug: Remigromig

What is being measured

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

Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Measured: Week 12

Secondary outcomes (2)

Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)
Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)
Measured: Duration of the study, through Week 12
Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Measured: Duration of the study, through Week 12

Timeline

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

12 Sep 202530 Jun 2028

First posted3 Oct 2025
Study start12 Sep 2025
Primary completion30 Jun 2028 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neovascular Age-Related Macular Degeneration (NVAMD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07205887
Sponsor's protocol ID: EYE-RES-104
Acronym: Super Tuscan
Status last verified: Oct 2026
First submitted: 24 Sep 2025
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No