NCT07205887 A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
| NCT ID | NCT07205887 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | EyeBiotech Ltd. |
| Condition | Neovascular Age-Related Macular Degeneration (NVAMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2025-09-12 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Charles Miller, MD PhD
STUDY DIRECTOR
EyeBiotech Ltd.
Frequently Asked Questions
Who can join the NCT07205887 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neovascular Age-Related Macular Degeneration (NVAMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07205887 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07205887 currently recruiting?
Yes, NCT07205887 is actively recruiting participants. Contact the research team at ClinicalInquiries@eyebiotech.com for enrollment information.
Where is the NCT07205887 trial being conducted?
This trial is being conducted at Scottsdale, United States, Scottsdale, United States, Glendale, United States, Glendale, United States and 11 additional locations.
Who is sponsoring the NCT07205887 clinical trial?
NCT07205887 is sponsored by EyeBiotech Ltd.. The principal investigator is Charles Miller, MD PhD at EyeBiotech Ltd.. The trial plans to enroll 160 participants.