Recruiting
Phase 2

EYE103

Sponsor:

EyeBiotech Ltd.

Code:

NCT07205887

Conditions

Neovascular Age-Related Macular Degeneration (NVAMD)

Branch Retinal Vein Occlusion (BRVO)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EYE103

Aflibercept 2.0 mg

Study Details

Brief summary:

EYE-RES-104 is a 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 EYE103 via IVT or a high dose of EYE103 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 EYE103 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.

Conditions

Neovascular Age-Related Macular Degeneration (NVAMD)

Branch Retinal Vein Occlusion (BRVO)

Study ID

NCT07205887

Start date

Sep 12, 2025

Status verified date

Sep, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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

Exclusion Criteria:

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

  • 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Naïve NVAMD - Low Dose EYE103

Treatment Naïve NVAMD Cohort - Low Dose EYE103 (50 μL)

experimental: Treatment Naïve NVAMD - High Dose EYE103

Treatment Naïve NVAMD Cohort - High Dose EYE103 (50 μL)

experimental: IR NVAMD - Low Dose EYE103

Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL)

experimental: IR NVAMD - High Dose EYE103

Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL)

experimental: IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg

Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg

experimental: IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg

Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg

experimental: Treatment Naïve BRVO - Low Dose EYE103

Treatment Naïve BRVO Cohort - Low Dose EYE103 (50 μL)

experimental: Treatment Naïve BRVO - High Dose EYE103

Treatment Naïve BRVO Cohort - High Dose EYE103 (50 μL)

Interventions

EYE103

EYE103 is a humanized antibody formulated for intravitreal administration

Aflibercept 2.0 mg

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 EYE103.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Locations

Scottsdale, Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Scottsdale, AZ

Recruiting

Scottsdale, Arizona, United States, 85255

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Glendale, California

Recruiting

Glendale, California, United States, 91204

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Glendale, CA

Recruiting

Glendale, California, United States, 91204

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Modesto, California

Recruiting

Modesto, California, United States, 95356

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Mountain View, California

Recruiting

Mountain View, California, United States, 94040

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Sacramento, CA

Recruiting

Sacramento, California, United States, 95825

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Sactamento, California

Recruiting

Sacramento, California, United States, 95825

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Sacramento, California

Recruiting

Sacramento, California, United States, 95841

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Santa Ana, California

Recruiting

Santa Ana, California, United States, 92705

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

RSC Research LLC

Recruiting

Denver, Colorado, United States, 80222

Contacts

Study Coordinator

720-443-2425

Fort Lauderdale, Florida

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Fort Lauderdale, FL

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Florida Retina Institute

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Study Coordinator

904-997-9202

Florida Retina Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

407-849-9621

Lemont, Illinois

Recruiting

Lemont, Illinois, United States, 60439

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Lemont, IL

Recruiting

Lemont, Illinois, United States, 60439

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Hagerstown, Maryland

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Hagerstown, MD

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Madison, Mississippi

Recruiting

Madison, Mississippi, United States, 39110

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Madison, MS

Recruiting

Madison, Mississippi, United States, 39110

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Bloomfield, New Jersey

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Bloomfield, NJ

Recruiting

Bloomfield, New Jersey, United States, 07003

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Long Island Vitreoretinal Consultants of NY

Recruiting

Great Neck, New York, United States, 11021

Contacts

Study Coordinator

516-466-0390

Asheville, North Carolina

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Cary, North Carolina

Recruiting

Cary, North Carolina, United States, 27511

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

North Carolina Retina Associates

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Study Coordinator

919-782-8038

Wake Forest, NC

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Wake Forest, North Carolina

Recruiting

Wake Forest, North Carolina, United States, 27587

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

West Columbia, SC

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

West Columbia, South Carolina

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Germantown, Tennessee

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Charles Miller, MD PhD

ClinicalInquiries@eyebiotech.com

Knoxville, Tennessee

Recruiting

Knoxville, Tennessee, United States, 37922

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Nashville, Tennessee

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Nashville, TN

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Abilene, Texas

Recruiting

Abilene, Texas, United States, 79606

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Amarillo, Texas

Recruiting

Amarillo, Texas, United States, 79106

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Austin, Texas

Recruiting

Austin, Texas, United States, 78705

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Austin, TX

Recruiting

Austin, Texas, United States, 78705

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Bellaire, Texas

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Bellaire, TX

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Burleson, Texas

Recruiting

Burleson, Texas, United States, 76028

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Dallas, Texas

Recruiting

Dallas, Texas, United States, 75231

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Dallas, TX

Recruiting

Dallas, Texas, United States, 75231

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Plano, Texas

Recruiting

Plano, Texas, United States, 75075

Contacts

Charles Miller, MD PhD

ClinicalInquiries@eyebiotech.com

Round Rock, TX

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Round Rock, Texas

Recruiting

Round Rock, Texas, United States, 78781

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

San Antonio, Texas

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

San Antonio, TX

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

San Marcos, Texas

Recruiting

San Marcos, Texas, United States, 78666

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

The Woodlands, Texas

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

The Woodlands, TX

Recruiting

The Woodlands, Texas, United States, 77384

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Willow Park, Texas

Recruiting

Willow Park, Texas, United States, 76087

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

West Jordan, Utah

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Charles Miller, MD PhD

212-914-0127ClinicalInquiries@eyebiotech.com

Retina Consultants, PLLC

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

Study Coordinator

304-346-4400

More Information

Sponsor

EyeBiotech Ltd.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Neovascular Age-Related Macular Degeneration
  • Branch Retinal Vein Occlusion
  • NVAMD
  • BRVO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by EyeBiotech Ltd. on 2026-09-04.