Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorEyebioKorea, Inc.
About this trial
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 50 years or older
Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20/40 to 20/320 in the Snellen chart)
Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study
Disqualifiers
Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)
Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded)
Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening
Subjects who have received intravitreal treatment using steroids
Trial design
Design model
Parallel
Treatments tested in this trial
EB-203
DrugSubjects will receive EB-203 according to the following dosage and administration method for each treatment group.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in central retinal thickness (CRT)
Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.
Time frame
Week 12Secondary outcomes
1
Change in BCVA
Change in BCVA at Weeks 4, 8, and 12 compared to baseline.
Time frame
Weeks 4, 8, 122
Change Proportion (%) in BCVA
Proportion (%) of subjects showing improvement in visual acuity of ≥ 1 line (5 letters on the ETDRS chart), ≥ 2 lines (10 letters on the ETDRS chart), and ≥ 3 lines (15 letters on the ETDRS chart) at Weeks 4, 8, and 12 weeks from baseline
Time frame
Weeks 4, 8, 123
Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid
Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid confirmed by OCT at Weeks 4, 8, and 12 weeks compared to baseline
Time frame
Weeks 4, 8, 124
Proportion (%) of subjects who received rescue medication
Proportion (%) of subjects who received rescue medication (anti-VEGF drug) at each visit
Time frame
Weeks 4, 8, 12Sponsors and contacts
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Source ClinicalTrials.gov