Clinical trial
Tolerating Subretinal Fluid in Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy Treated Using Aflibercept
Name
2022-09-004
Description
The purpose of the present study was to evaluate the outcomes of type 1 macular neovascularization (MNV), including polypoidal choroidal vasculopathy in patients treated tolerating subretinal fluid (SRF) using Aflibercept in a clinical setting. Approximately 150 patients are anticipated to be enrolled in this study. SRF is a primary type of fluid compartment prevalent in type 1 aneurysmal MNV. In a recent study, the prevalence of SRF during 24-month follow-up period was 36.7% to 38.8% in type 1 MNV and polypoidal choroidal vasculopathy (PCV), 20.0% in type 2 MNV, and 7.7% in type 3 MNV. In addition, patients with SRF showed better visual prognosis in type 1 MNV/PCV. For this reason, type 1 MNV is an appropriate candidate for evaluating the influence of tolerating SRF.
Trial arms
Trial start
2022-12-05
Estimated PCD
2023-05-31
Trial end
2023-11-30
Status
Completed
Treatment
Intravitreal aflibercept injection
Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)
Arms:
Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy
Size
135
Primary endpoint
Changes in visual acuity
Through study completion, an average of 20 months
Eligibility criteria
Inclusion Criteria:
* Patient who were diagnosed with type 1 MNV or PCV
* Patients who were treated using aflibercept between January 2021 and December 2022
* Patients underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months.
Exclusion Criteria:
* Less than 6 months of tolerating-fluid phase
* Patients without indocyanine green angiography (ICGA) result
* Patients who received other treatment for neovascular age-related macular degeneration (AMD), except for aflibercept (eg. ranibizumab, bevacizumab, or PDT)
* History of intraocular or periocular steroid injection
* History of vitreoretinal surgery or glaucoma surgery
* History of intraocular inflammation
* Uncontrolled glaucoma (IOP ≥ 25mmHg)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}
Updated at
2023-12-14
1 organization
1 product
3 indications
Organization
Kim's Eye HospitalProduct
Intravitreal afliberceptIndication
Polypoidal Choroidal VasculopathyIndication
Choroidal NeovascularizationIndication
Age-related macular degeneration