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

NCT07205887 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EYE-RES-104
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 49

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Secondary Outcomes (2)

• Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT)

  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

  Duration of the study, through Week 12

Study Arms (8)

Treatment Naïve NVAMD - Low Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

Treatment Naïve NVAMD - High Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

IR NVAMD - Low Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

IR NVAMD - High Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

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

EXPERIMENTAL

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

Drug: EYE103; Drug: Aflibercept 2.0 mg

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

EXPERIMENTAL

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

Drug: EYE103; Drug: Aflibercept 2.0 mg

Treatment Naïve BRVO - Low Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

Treatment Naïve BRVO - High Dose EYE103

EXPERIMENTAL

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

Drug: EYE103

Interventions

EYE103 DRUG

EYE103 is a humanized antibody formulated for intravitreal administration

Also known as: Restoret

IR NVAMD - High Dose EYE103; IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg; IR NVAMD - Low Dose EYE103; IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg; Treatment Naïve BRVO - High Dose EYE103; Treatment Naïve BRVO - Low Dose EYE103; Treatment Naïve NVAMD - High Dose EYE103; Treatment Naïve NVAMD - Low Dose EYE103

Aflibercept 2.0 mg DRUG

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.

IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg; IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg

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.
• Be ≥ 50 years of age
• Have treatment naive subfoveal CNV secondary to 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
• Be ≥ 50 years of age
• Have treatment naive subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
• For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Screening Visit 2
• 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

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 had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
• Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
• Have had previous thermal subfoveal laser therapy in the study eye
• Have had previous photodynamic therapy with Visudyne in the study eye
• Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, DME, NVAMD, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye

Sponsors & Collaborators

• EyeBiotech Ltd.: lead

Study Sites (49)

Scottsdale, Arizona

Scottsdale, Arizona, 85255, United States

RECRUITING

Scottsdale, AZ

Scottsdale, Arizona, 85255, United States

RECRUITING

Glendale, California

Glendale, California, 91204, United States

RECRUITING

Glendale, CA

Glendale, California, 91204, United States

RECRUITING

Modesto, California

Modesto, California, 95356, United States

RECRUITING

Mountain View, California

Mountain View, California, 94040, United States

RECRUITING

Sacramento, CA

Sacramento, California, 95825, United States

RECRUITING

Sactamento, California

Sacramento, California, 95825, United States

RECRUITING

Sacramento, California

Sacramento, California, 95841, United States

RECRUITING

Santa Ana, California

Santa Ana, California, 92705, United States

RECRUITING

Fort Lauderdale, Florida

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Fort Lauderdale, FL

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Lemont, Illinois

Lemont, Illinois, 60439, United States

RECRUITING

Lemont, IL

Lemont, Illinois, 60439, United States

RECRUITING

Hagerstown, Maryland

Hagerstown, Maryland, 21740, United States

RECRUITING

Hagerstown, MD

Hagerstown, Maryland, 21740, United States

RECRUITING

Madison, Mississippi

Madison, Mississippi, 39110, United States

RECRUITING

Madison, MS

Madison, Mississippi, 39110, United States

RECRUITING

Bloomfield, New Jersey

Bloomfield, New Jersey, 07003, United States

RECRUITING

Bloomfield, NJ

Bloomfield, New Jersey, 07003, United States

RECRUITING

Asheville, North Carolina

Asheville, North Carolina, 28803, United States

RECRUITING

Cary, North Carolina

Cary, North Carolina, 27511, United States

RECRUITING

Wake Forest, NC

Wake Forest, North Carolina, 27587, United States

RECRUITING

Wake Forest, North Carolina

Wake Forest, North Carolina, 27587, United States

RECRUITING

West Columbia, SC

West Columbia, South Carolina, 29169, United States

RECRUITING

West Columbia, South Carolina

West Columbia, South Carolina, 29169, United States

RECRUITING

Germantown, Tennessee

Germantown, Tennessee, 38138, United States

RECRUITING

Knoxville, Tennessee

Knoxville, Tennessee, 37922, United States

RECRUITING

Nashville, Tennessee

Nashville, Tennessee, 37203, United States

RECRUITING

Nashville, TN

Nashville, Tennessee, 37203, United States

RECRUITING

Abilene, Texas

Abilene, Texas, 79606, United States

RECRUITING

Amarillo, Texas

Amarillo, Texas, 79106, United States

RECRUITING

Austin, Texas

Austin, Texas, 78705, United States

RECRUITING

Austin, TX

Austin, Texas, 78705, United States

RECRUITING

Bellaire, Texas

Bellaire, Texas, 77401, United States

RECRUITING

Bellaire, TX

Bellaire, Texas, 77401, United States

RECRUITING

Burleson, Texas

Burleson, Texas, 76028, United States

RECRUITING

Dallas, Texas

Dallas, Texas, 75231, United States

RECRUITING

Dallas, TX

Dallas, Texas, 75231, United States

RECRUITING

Plano, Texas

Plano, Texas, 75075, United States

RECRUITING

Round Rock, TX

Round Rock, Texas, 78681, United States

RECRUITING

Round Rock, Texas

Round Rock, Texas, 78781, United States

RECRUITING

San Antonio, Texas

San Antonio, Texas, 78240, United States

RECRUITING

San Antonio, TX

San Antonio, Texas, 78240, United States

RECRUITING

San Marcos, Texas

San Marcos, Texas, 78666, United States

RECRUITING

The Woodlands, Texas

The Woodlands, Texas, 77384, United States

RECRUITING

The Woodlands, TX

The Woodlands, Texas, 77384, United States

RECRUITING

Willow Park, Texas

Willow Park, Texas, 76087, United States

RECRUITING

West Jordan, Utah

West Jordan, Utah, 84088, United States

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles Miller, MD PhD

  EyeBiotech Ltd.

  STUDY DIRECTOR

Central Study Contacts

Charles Miller, MD PhD

CONTACT

212-914-0127; ClinicalInquiries@eyebiotech.com

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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

US (49)