Neovascular Age-related Macular Degeneration (nAMD)Phase 2NCT06487039
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
A Phase 2 study testing EB-203 in people with Neovascular Age-related Macular Degeneration (nAMD), run by EyebioKorea, Inc. at 5 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD)
- What is being tested?
- EB-203
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Aug 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area
- Subjects with vitreous hemorrhage in the study eye
Show all 10Show fewer
- Subjects who have undergone vitrectomy
- Subjects with a history of retinal detachment, congenital disease, or treatment and/or surgical history for retinal detachment
- Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye
- Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Busan Paik Hospital, Inje University
Busan, 47392
Dong Geun Kim, kidogu@naver.com
- Recruiting
Pusan National University Hospital
Busan, 49241
Iksoo Byon, isbyon@naver.com
- Recruiting
Yeungnam University Medical Center
Daegu, 42415
Min Sagong, msagong@yu.ac.kr
- Recruiting
Kim's Eye Hospital
Seoul, 08858
Jae Jui Kim, kjh7997@daum.net
- Recruiting
Seoul National University Hospital
Seoul, 08858
KyuHyeong PARK, jiani4@snu.ac.kr
KyuHyeong PARK
About this study
Official title: A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
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)
Read the detailed description
This study is a double-blind, parallel, multicenter-phase 2a study to evaluate the safety and efficacy of EB-203 in patients with nAMD.
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Final subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio into Group A(EB-203 2%, 4 times a day) and Group B (EB-203 4%, 4 times a day).
Randomization will be performed using the study institution (hereinafter "institution") as a stratification factor.
Subjects will receive the investigational products according to the group to which they are randomized.
Safety and tolerability will be assessed for 12 weeks after randomization. Efficacy will be assessed at Weeks 4, 8, and 12. In addition, subjects will be monitored by visiting the institution 4 weeks after the last dose of the investigational product (Visit 8).
If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.
From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.
If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).
- Being tested
- EB-203
- Keywords
- nAMD, eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-203Drug
Subjects will receive EB-203 according to the following dosage and administration method for each treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | EB-203 2% QID Receives: Drug: EB-203 |
| Group B | Experimental | EB-203 4% QID Receives: Drug: EB-203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central retinal thickness (CRT)
Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.
Measured: Week 12
Secondary outcomes (4)
Change in BCVA
Change in BCVA at Weeks 4, 8, and 12 compared to baseline.
Measured: Weeks 4, 8, 12
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
Measured: Weeks 4, 8, 12
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
Measured: Weeks 4, 8, 12
Proportion (%) of subjects who received rescue medication
Proportion (%) of subjects who received rescue medication (anti-VEGF drug) at each visit
Measured: Weeks 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: EB-203 2% QID Group B: EB-203 4% QID
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyebioKorea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Hyeong Park, Study chair, Seoul National University HospitalSeoul National University HospitalJaeHui Kim, Principal investigator, Kim's Eye HospitalIksoo Byon, Principal investigator, Pusan National University HospitalMin Sagong, Principal investigator, Yeungnam University HospitalDong Geun Kim, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487039
- Sponsor's protocol ID
- EB-203-201
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specify the Plan to Share IPD: All outcome data, including anonymized individual participant data, will be shared. What IPD Will Be Shared: Demographic information of participants, primary outcome data, secondary outcome data, analysis code, etc. When Will IPD Be Available: Data will be shared starting 6 months after the trial ends and will be available for at least 5 years. Under What Conditions Will IPD Be Shared: Data will be available for research purposes only and will be provided to approved researchers. How to Access the Shared IPD: Researchers must submit a data access request form. Access to the data will be granted upon approval of the request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06487039
- Acronym / sponsor ID
- EB-203-201
- Keywords
- nAMD, eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EyebioKorea, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
This study is a double-blind, parallel, multicenter-phase 2a study to evaluate the safety and efficacy of EB-203 in patients with nAMD.
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Final subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio into Group A(EB-203 2%, 4 times a day) and Group B (EB-203 4%, 4 times a day).
Randomization will be performed using the study institution (hereinafter "institution") as a stratification factor.
Subjects will receive the investigational products according to the group to which they are randomized.
Safety and tolerability will be assessed for 12 weeks after randomization. Efficacy will be assessed at Weeks 4, 8, and 12. In addition, subjects will be monitored by visiting the institution 4 weeks after the last dose of the investigational product (Visit 8).
If a subject meets the criteria for the administration of rescue medication at Visit 3 (Week 2), he/she will be withdrawn from the study.
From Visit 4 (Week4), subjects may be withdrawn from the study based on the withdrawal criteria for each visit or the criteria for the administration of rescue medication.
If a subject who meets the criteria for the administration of rescue medication for each visit is withdrawn from the study, he/she will be administered the anti-VEGF drug aflibercept (product name: Eylea Injection®) once (intraocular injection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Group A: EB-203 2% QID Group B: EB-203 4% QID
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: EB-203EB-203 2% QID |
| Group B | Experimental | Drug: EB-203EB-203 4% QID |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-203Subjects will receive EB-203 according to the following dosage and administration method for each treatment group. | Drug | Group A, Group B |
Primary outcome
Change in central retinal thickness (CRT)
Time frame: Week 12
Change in central retinal thickness (CRT) measured by OCT at Week 12 compared to baseline.
4 secondary outcomes
Change in BCVA
Time frame: Weeks 4, 8, 12
Change Proportion (%) in BCVA
Time frame: Weeks 4, 8, 12
Proportion (%) of subjects with complete disappearance of intraretinal and subretinal fluid
Time frame: Weeks 4, 8, 12
Proportion (%) of subjects who received rescue medication
Time frame: Weeks 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Yes. Specify the Plan to Share IPD: All outcome data, including anonymized individual participant data, will be shared. What IPD Will Be Shared: Demographic information of participants, primary outcome data, secondary outcome data, analysis code, etc. When Will IPD Be Available: Data will be shared starting 6 months after the trial ends and will be available for at least 5 years. Under What Conditions Will IPD Be Shared: Data will be available for research purposes only and will be provided to approved researchers. How to Access the Shared IPD: Researchers must submit a data access request form. Access to the data will be granted upon approval of the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Hyeong Park study chair
Seoul National University HospitalSeoul National University Hospital
JaeHui Kim principal investigator
Kim's Eye Hospital
Iksoo Byon principal investigator
Pusan National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB-203 in people with Neovascular Age-related Macular Degeneration (nAMD), run by EyebioKorea, Inc. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SUYEON KIM (1047070314 ext. 82, suyeon@eyebiokorea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in central retinal thickness (CRT) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.