Actively Recruiting
Open-Label, Multiple Ascending Dose Phase 1b/2a Study of the Safety and Tolerability of Intravitreal EYC-0305 in Patients With Neovascular Age-Related Macular Degeneration
Led by Eyconis INC. · Updated on 2026-05-22
30
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying EYC-0305, an extended-delivery anti-VEGF biological treatment, in patients aged 50 and older with neovascular (wet) age-related macular degeneration (AMD). The main focus is to assess the safety and tolerability of EYC-0305 when given by intravitreal injection every 24 weeks. The study also evaluates how the drug affects disease activity, vision, and its behavior in the body, including immune response and drug levels. This is an open-label Phase 1b/2a study with multiple increasing dose levels of EYC-0305. Participants will receive injections directly into the eye at set intervals of 24 weeks, with four dose levels being studied. The study does not include a placebo group and does not involve masking or blinding. The treatment period extends to 72 weeks to monitor safety and effects over time. Participants will attend clinic visits for injections and monitoring throughout the study. Researchers will assess the incidence and severity of any eye-related or systemic adverse events up to week 72. Additional tests and imaging may be performed to track disease activity and vision changes. The total study duration allows for ongoing evaluation of safety, drug levels, and immune response under medical supervision.
CONDITIONS
Brief Title
Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 50 years and older with neovascular (wet) AMD meeting all study eligibility criteria
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
You will not qualify if you...
- Known hypersensitivity or allergy preventing study drug administration
- Unable to obtain ophthalmic imaging due to media opacity, poor pupil dilation, allergy to fluorescein dye, or lack of venous access
- Uncontrolled diabetes mellitus
- History of stroke or heart attack within 180 days before study start
- Renal failure, dialysis, or history of kidney transplant
- Psychiatric or medical conditions interfering with study participation
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 weeks
Participants receive intravitreal injections of EYC-0305 at ascending dose levels to assess safety and tolerability.
Multiple visits for dosing and safety assessments throughout treatment
Trial Site Locations
Total: 5 locations
1
Beverly Hills, CA
Beverly Hills, California, United States, 90211
Not Yet Recruiting
2
Erie, PA
Erie, Pennsylvania, United States, 16505
Actively Recruiting
3
Bellaire, TX
Bellaire, Texas, United States, 77401
Not Yet Recruiting
4
McAllen, TX
McAllen, Texas, United States, 78503
Actively Recruiting
5
The Woodlands, TX
The Woodlands, Texas, United States, 77384
Not Yet Recruiting
Research Team
K
Kim Reed, OD, FAAO
K
Karen Chu, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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