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

NCT06330220 | Completed Phase 4 DMC

• 1 other identifier: 2010-015-1161
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Age-Related Macular Degeneration

Outcome Measures

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

  12 weeks

Secondary Outcomes (1)

• The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry

  12 weeks

Study Arms (1)

Aflibercept loading

EXPERIMENTAL

Administration of 2㎎ intravitreal aflibercept three times monthly after diagnosis

Drug: Aflibercept Injection [Eylea]

Interventions

Aflibercept Injection [Eylea] DRUG

intravitreal injection

Also known as: Eylea injection

Aflibercept loading

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Chang Ki Yoon, Ph.D

  Seoul National University College of Medicine, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: February 10, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

KR (1)