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

RecruitingPhase 2

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)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: EyeBiotech Ltd. · Participants: 160 · Started: Sep 12, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07205887

Locations in the U.S.

ArizonaScottsdale, AZ, Scottsdale
Scottsdale, Arizona, Scottsdale
CaliforniaGlendale, CA, Glendale
Glendale, California, Glendale
Modesto, California, Modesto
Mountain View, California, Mountain View
Sacramento, CA, Sacramento
Sacramento, California, Sacramento
Sactamento, California, Sacramento
Santa Ana, California, Santa Ana
ColoradoRSC Research LLC, Denver
FloridaFort Lauderdale, FL, Fort Lauderdale
Fort Lauderdale, Florida, Fort Lauderdale
Florida Retina Institute, Jacksonville
Florida Retina Institute, Orlando
IllinoisLemont, IL, Lemont
Lemont, Illinois, Lemont
MarylandHagerstown, MD, Hagerstown
Hagerstown, Maryland, Hagerstown
MississippiMadison, MS, Madison
Madison, Mississippi, Madison
New JerseyBloomfield, NJ, Bloomfield
Bloomfield, New Jersey, Bloomfield
New YorkLong Island Vitreoretinal Consultants of NY, Great Neck
North CarolinaAsheville, North Carolina, Asheville
Cary, North Carolina, Cary
North Carolina Retina Associates, Greenville
Wake Forest, NC, Wake Forest
Wake Forest, North Carolina, Wake Forest
South CarolinaWest Columbia, SC, West Columbia
West Columbia, South Carolina, West Columbia
TennesseeGermantown, Tennessee, Germantown
Knoxville, Tennessee, Knoxville
Nashville, TN, Nashville
Nashville, Tennessee, Nashville
TexasAbilene, Texas, Abilene
Amarillo, Texas, Amarillo
Austin, TX, Austin
Austin, Texas, Austin
Bellaire, TX, Bellaire
Bellaire, Texas, Bellaire
Burleson, Texas, Burleson
Dallas, TX, Dallas
Dallas, Texas, Dallas
Plano, Texas, Plano
Round Rock, TX, Round Rock
Round Rock, Texas, Round Rock
San Antonio, TX, San Antonio
San Antonio, Texas, San Antonio
San Marcos, Texas, San Marcos
The Woodlands, TX, The Woodlands
The Woodlands, Texas, The Woodlands
Willow Park, Texas, Willow Park
UtahWest Jordan, Utah, West Jordan
West VirginiaRetina Consultants, PLLC, Charleston

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.