Status:
RECRUITING
A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
Lead Sponsor:
EyeBiotech Ltd.
Conditions:
Neovascular Age-Related Macular Degeneration (NVAMD)
Branch Retinal Vein Occlusion (BRVO)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Be male or female ≥18 years of age.
- Key NVAMD-specific Inclusion Criteria
- 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
- Key IR NVAMD-specific Inclusion Criteria
- 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
- Key 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
- Key General Exclusion Criteria
- 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)
- 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, DME, NVAMD, Irvine-Gass syndrome)
- Have active iris or angle neovascularization or neovascular glaucoma in the study eye
Key Trial Info
Start Date :
September 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07205887
Start Date
September 12 2025
End Date
June 30 2028
Last Update
November 19 2025
Active Locations (49)
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1
Scottsdale, Arizona
Scottsdale, Arizona, United States, 85255
2
Scottsdale, AZ
Scottsdale, Arizona, United States, 85255
3
Glendale, California
Glendale, California, United States, 91204
4
Glendale, CA
Glendale, California, United States, 91204