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A Randomized, Double-blind, Parallel, Multicenter Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Led by EyebioKorea, Inc. · Updated on 2024-08-27
50
Participants Needed
5
Research Sites
21 weeks
Total Duration
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AI-Summary
What this Trial Is About
This trial investigates the safety and effectiveness of EB-203 in adults aged 50 years or older with neovascular Age-related Macular Degeneration (nAMD). The study is a double-blind, parallel, multicenter Phase 2a trial aiming primarily to assess the safety and tolerability of two different doses of EB-203. It also looks at how well the treatment works in improving vision and retinal health in people with nAMD. Participants who meet the study criteria will be randomly assigned to one of two groups receiving either EB-203 2% or EB-203 4%, both administered four times daily. The study includes a 12-week treatment period during which participants receive the assigned dose of EB-203. Safety and tolerability are monitored throughout this period, with efficacy assessments at Weeks 4, 8, and 12. After the last dose, participants return for a follow-up visit 4 weeks later. If participants require rescue medication, they may be withdrawn and treated with an anti-VEGF injection called aflibercept. During the study, participants will undergo regular eye exams and assessments of vision using standardized charts. Researchers will measure changes in central retinal thickness and visual acuity at specified times. They will also monitor the presence or absence of fluid in the retina and record any need for rescue medication. The total duration of participation is approximately 16 weeks, including treatment and follow-up visits to ensure safety and evaluate outcomes.
CONDITIONS
Brief Title
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- Best corrected visual acuity (BCVA) score between 25 and 73 on the ETDRS chart at 4 meters (equivalent to 20/40 to 20/320 on Snellen chart)
- Voluntary signing of informed consent after receiving study information
You will not qualify if you...
- Need for standard treatment in both eyes for confirmed neovascular Age-related Macular Degeneration (dry AMD allowed in non-study eye)
- Prior ocular or systemic treatment for nAMD such as photodynamic therapy or laser photocoagulation, or surgery for nAMD
- Prior anti-VEGF drug treatment or combination therapy for nAMD in the study eye before screening
- Previous intravitreal steroid treatment
- Subretinal hemorrhage involving 50% or more of the lesion area or hemorrhage in the subfoveal region exceeding 1 optic disk area
- Vitreous hemorrhage in the study eye
- History of vitrectomy
- History of retinal detachment, congenital retinal disease, or surgery related to retinal detachment
- Scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
- Choroidal neovascularization from causes other than nAMD (except polypoidal choroidal vasculopathy)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive EB-203 eye drops four times a day at one of two different concentrations depending on their assigned group. Safety and efficacy are assessed during this period.
Visits at Weeks 2, 4, 8, and 12 for assessments and dosing evaluation
Duration - 4 weeks
Participants are monitored for safety and treatment effects after completing the treatment period.
1 visit approximately 4 weeks after the last dose
Trial Site Locations
Total: 5 locations
1
Busan Paik Hospital, Inje University
Busan, South Korea, 47392
Actively Recruiting
2
Pusan National University Hospital
Busan, South Korea, 49241
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3
Yeungnam University Medical Center
Daegu, South Korea, 42415
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4
Kim's Eye Hospital
Seoul, South Korea, 08858
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5
Seoul National University Hospital
Seoul, South Korea, 08858
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Research Team
S
SUYEON KIM
Y
YUNSEOK CHO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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