Age-Related Macular DegenerationPhase 4NCT06330220
Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity
A Phase 4 study testing Aflibercept Injection [Eylea] in people with Age-Related Macular Degeneration, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Aflibercept Injection [Eylea]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2021to 28 Feb 2022
- Phase
- Phase 4
- 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
- Age equal to or older than 50 years
- Treatment Naïve with active subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye
- Baseline visual acuity equal to or better than 20/40
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Willingness and ability to undertake all scheduled visits and assessments
Who cannot join
- Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
- Scar, fibrosis or atrophy involving the center of the fovea in the study eye
- Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- Presence of macular hole at any stage in the study eye
- Any concurrent macular abnormality other than AMD in the study eye including epiretinal membrane, macular telangiectasia, retinal vascular abnormality.
Show all 17Show fewer
- History of intraocular surgery except cataract operation
- Any previous intravitreal treatment to treat neovascular AMD in study eye.
- Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
- Presence of glaucoma that affect visual field in the study eye
- Uncontrolled ocular hypertension in the study eye (defined as intraocular pressure ≥ 25 mg despite treatment with anti-glaucoma medication) in the study eye
- History of allergy to the fluorescein sodium for injection in angiography
- History or clinical evidence of diabetic retinopathy much severe than mild non-proliferative diabetic retinopathy or diabetic macular edema in either eye
- Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to screening
- Prior treatment involving macula with photodynamic therapy with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment in the study eye, and such medications will not be allowed during the study period.
- Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin and ethambutol, and such medications will not be allowed during the study period.
- Patients incapable of performing diagnostic tests for reasons including physical or attention limitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography and Microperimetry After Aflibercept in Wet Age-related Macular Degeneration Patients With the Better Baseline Visual Acuity (≥20/40)
Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40).
Read the detailed description
This study is designed to show the clinical effect of aflibercept in early disease course for wet age-related macular degeneration (AMD) with better visual acuity. It is important to extend the usage of aflibercept and give the treatment chance to patient.
VIEW 1 and VIEW 2 Study demonstrated that aflibercept was excellent treatment for choroidal neovascularization secondary to AMD, but the study enrolled patients with a range of visual acuity (20/40 to 20/320). A previous study with ranibizumab, Marina and Anchor studies also had the same inclusion criteria with VIEW studies. Recently, the number of wet AMD patients with the better visual acuity is increasing. However, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'.
The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40). And correlation of optical coherence tomography angiography (OCTA) findings and microperimetry will be evaluated to provide investigators with additional data about the effects of therapeutic agents.
In this study, the aflibercept will be treated according to the Ministry of Food and drug safety guideline. Also, the patients will be provided with aflibercept, microperimetry and imaging tests (fluorescein angiography, indocyanine green angiography, optical coherence tomography and OCTA).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Aflibercept Injection [Eylea]
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection [Eylea]Drug
Also called Eylea injection
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept loading | Experimental | Administration of 2㎎ intravitreal aflibercept three times monthly after diagnosis Receives: Drug: Aflibercept Injection [Eylea] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients
Visual function changes by assessing retinal sensitivity changes using microperimetry after aflibercept loading injection in wet age-related macular degeneration patients
Measured: 12 weeks
Secondary outcomes (1)
The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry
OCT and OCT angiography parameters associated with retinal sensitivity change
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Ki Yoon, Seoul National University Hospital
- Investigators
- Chang Ki Yoon, Ph.D, Principal investigator, Seoul National University College of Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330220
- Sponsor's protocol ID
- 2010-015-1161
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography and Microperimetry After Aflibercept in Wet Age-related Macular Degeneration Patients With the Better Baseline Visual Acuity (≥20/40)
- ClinicalTrials.gov ID
- NCT06330220
- Acronym / sponsor ID
- 2010-015-1161
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Mar 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.
Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40).
Detailed description
This study is designed to show the clinical effect of aflibercept in early disease course for wet age-related macular degeneration (AMD) with better visual acuity. It is important to extend the usage of aflibercept and give the treatment chance to patient.
VIEW 1 and VIEW 2 Study demonstrated that aflibercept was excellent treatment for choroidal neovascularization secondary to AMD, but the study enrolled patients with a range of visual acuity (20/40 to 20/320). A previous study with ranibizumab, Marina and Anchor studies also had the same inclusion criteria with VIEW studies. Recently, the number of wet AMD patients with the better visual acuity is increasing. However, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'.
The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40). And correlation of optical coherence tomography angiography (OCTA) findings and microperimetry will be evaluated to provide investigators with additional data about the effects of therapeutic agents.
In this study, the aflibercept will be treated according to the Ministry of Food and drug safety guideline. Also, the patients will be provided with aflibercept, microperimetry and imaging tests (fluorescein angiography, indocyanine green angiography, optical coherence tomography and OCTA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept loading | Experimental | Drug: Aflibercept Injection [Eylea]Administration of 2㎎ intravitreal aflibercept three times monthly after diagnosis |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age equal to or older than 50 years
- Treatment Naïve with active subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye
- Baseline visual acuity equal to or better than 20/40
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Willingness and ability to undertake all scheduled visits and assessments
Key exclusion criteria (17 listed)
- Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion in the study eye
- Scar, fibrosis or atrophy involving the center of the fovea in the study eye
- Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- Presence of macular hole at any stage in the study eye
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 |
|---|---|---|
| Aflibercept Injection [Eylea]Also: Eylea injectionintravitreal injection | Drug | Aflibercept loading |
Primary outcome
Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients
Time frame: 12 weeks
Visual function changes by assessing retinal sensitivity changes using microperimetry after aflibercept loading injection in wet age-related macular degeneration patients
1 secondary outcome
The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
Chang Ki Yoon, Ph.D principal investigator
Seoul National University College of Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept Injection [Eylea] in people with Age-Related Macular Degeneration, run by Seoul National University Hospital at 1 site 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients (time frame: 12 weeks). 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 26 Mar 2024.