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CompletedNCT06330220Updated Mar 26, 2024

Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity

A Phase 4 interventional study of Aflibercept Injection [Eylea] in Age-Related Macular Degeneration, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Feb 2021, registered Mar 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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'. 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).

02

Conditions studied

  • Age-Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 12 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Aflibercept loading

    Administration of 2㎎ intravitreal aflibercept three times monthly after diagnosis

    Drug: Aflibercept Injection [Eylea]

Interventions

  • DrugAflibercept Injection [Eylea]

    intravitreal injection

    Also known as: Eylea injection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 12 weeks

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06330220
Lead sponsor
Seoul National University Hospital
Responsible party
Chang Ki Yoon (Clinical Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 26, 2024
Start date
Feb 10, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
Mar 26, 2024

Study contacts

Chang Ki Yoon, Ph.D
principal investigator · Seoul National University College of Medicine, Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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