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New treatment option for Neovascular Age-Related Macular Degeneration (NVAMD)
Official title A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
ClinicalTrials.gov ID: NCT07205887
What this study is testing
What is EYE103?
EYE103 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for neovascular age-related macular degeneration (nvamd).
Also referred to as Restoret.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key General Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first...
- Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV...
- 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...
- 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...
You likely can't join if
- 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...
- Have had previous thermal subfoveal laser therapy in the study eye
See the full eligibility criteria
- Key General 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...
- 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 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 Be diagnosed with BRVO in the...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Glendale, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Sacramento, California, United States
- Santa Ana, California, United States
- Fort Lauderdale, Florida, United States
- Lemont, Illinois, United States
- Hagerstown, Maryland, United States
- Madison, Mississippi, United States
- Bloomfield, New Jersey, United States
- Asheville, North Carolina, United States
- Cary, North Carolina, United States
- Wake Forest, North Carolina, United States
- West Columbia, South Carolina, United States
- Germantown, Tennessee, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Abilene, Texas, United States
- Amarillo, Texas, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Glendale, California, United States; Modesto, California, United States; Mountain View, California, United States; Sacramento, California, United States; Santa Ana, California, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.