No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
EyeBiotech Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with eye conditions caused by age-related macular degeneration or branch retinal vein occlusion. Participants will receive three injections of a study medication into the eye over a period of 12 weeks and will return for follow-up assessments.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 50 years old
I have been diagnosed with neovascular age-related macular degeneration or macular edema due to branch retinal vein occlusion
I have not received any previous treatment for my condition
I understand the study and agree to participate
You may not be able to join if
I am pregnant or breastfeeding
I have had cataract or glaucoma surgery in the study eye in the past 3 months
I have had certain types of laser treatment in the study eye
I am currently taking medications that can harm my retina
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
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. 4…
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).
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.
Trial Locations
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Status
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
* B…
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
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