Clinical trial NCT06330220: Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients
timeFrame: 12 weeks
Secondary outcomes:
measure: The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine, Seoul National University Hospital
name: Chang Ki Yoon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: