Outcomes of Tolerating Subretinal Fluid in Type 1 MNV and PCV

December 7, 2023 updated by: Kim's Eye Hospital

Tolerating Subretinal Fluid in Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy Treated Using Aflibercept

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tolerating subretinal fluid (SRF) is one of the current major issues in the field of neovascular age-related macular degeneration. Previous post-hoc analysis studies have demonstrated that SRF is not associated with poor visual acuity as well as poor visual outcome. In addition, previous studies showed that tolerating small amount of SRF may not influence visual outcome when using treat-and-extend regimen. Based on these observations, it is generally accepted that small stable amounts of SRF can be tolerated.

To date, several clinical trials evaluated association of residual SRF with visual outcome. In these clinical trials, treatment was performed based on strict study protocol. In addition, strict rescue treatment criteria impeded definite under-treatment. However, in a clinical setting, non-scientific factors such as financial or time burden, fear to injection and compliance can influence treatment decisions. As a result, in some patients, more intensive treatment cannot be performed despite substantial amount of persistent retinal fluid.

Unlike clinical trials, in real-world practice it is difficult to precisely measure and tolerate fluid in strict amounts. As a result, large degree of fluctuation of fluid volume can occur in some patients. In addition, large amounts of fluid, which may not be tolerated in clinical trials, can persist for a relatively long period. Such cases are usually difficult to encounter in clinical trials because these patients are either treated more intensively or are dropped from the trial. Investigating the outcomes in these cases can provide useful information that cannot be obtained from clinical trials.

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 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 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.

This study may contribute to the better understanding the influence of tolerating SRF on treatment outcomes in patients diagnosed with this subtype of neovascular age-related macular degeneration (AMD). In addition, it may also contribute to the evolution of aflibercept T&E therapy, and provide evidence for physicians to guide treatment decisions.

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients were diagnosed with type 3 MNV or PCV and underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 Macular Neovascularization and Polypoidal Choroidal Vasculopathy
Patients with type 1 macular neovascularization and polypoidal choroidal vasculopathy who underwent continuous aflibercept injections with tolerating subfoveal retinal fluid more than 6 months
Drug: Intravitreal aflibercept injection
Intravitreal injection of aflibercept (0.2 mg / 0,05 ml; Bayer Co. Ltd.,)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in visual acuity
Time Frame: Through study completion, an average of 20 months
Change in best-corrected visual acuity (BCVA) between the start and the end of treatment tolerating subretinal fluid
Through study completion, an average of 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who exhibited deterioration of ≥0.3 logMAR BCVA
Time Frame: Through study completion, an average of 20 months
Proportion of patients who exhibited deterioration of ≥0.3 logMAR BCVA between the start and the end of treatment tolerating subretinal fluid
Through study completion, an average of 20 months
Difference in the BCVA change, according to MNV subtype
Time Frame: Through study completion, an average of 20 months
Difference in the BCVA change, according to MNV subtype (type 1 MNV vs PCV)
Through study completion, an average of 20 months
Degree of visual deterioration according to the treatment period
Time Frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the treatment period
Through study completion, an average of 20 months
Degree of visual deterioration according to the height of SRF
Time Frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the height of SRF
Through study completion, an average of 20 months
Degree of visual deterioration according to the fluctuation of SRF height
Time Frame: Through study completion, an average of 20 months
Degree of visual deterioration according to the fluctuation of SRF height
Through study completion, an average of 20 months
Comparison of visual outcomes between the following three groups (mean SRF height <100 µm vs ≥100 µm, <200 µm vs ≥200 µm)
Time Frame: Through study completion, an average of 20 months
Comparison of visual outcomes between the following three groups (mean SRF height <100 µm vs ≥100 µm, <200 µm vs ≥200 µm)
Through study completion, an average of 20 months
Proportion of patients in whom the intraretinal fluid (IRF) developed during treatment tolerating SRF
Time Frame: Through study completion, an average of 20 months
Proportion of patients in whom the IRF developed during treatment tolerating SRF
Through study completion, an average of 20 months
Difference in visual outcome between patients with and without IRF development
Time Frame: Through study completion, an average of 20 months
Difference in visual outcome between patients with and without IRF development
Through study completion, an average of 20 months
Risk factors of IRF development
Time Frame: Through study completion, an average of 20 months
Risk factors of IRF development
Through study completion, an average of 20 months
The incidence of vision-threatening event such as large submacular hemorrhage or tear of retinal pigment epithelium
Time Frame: Through study completion, an average of 20 months
The incidence of vision-threatening event such as large submacular hemorrhage or tear of retinal pigment epithelium
Through study completion, an average of 20 months
The incidence of SRF resolution without shortening injection interval
Time Frame: Through study completion, an average of 20 months
The incidence of SRF resolution without shortening injection interval
Through study completion, an average of 20 months
Risk factor of developing deterioration of ≥0.2 logMAR BCVA
Time Frame: Through study completion, an average of 20 months
Risk factor of developing deterioration of ≥0.2 logMAR BCVA
Through study completion, an average of 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kim's Eye Hospital

Investigators

  • Principal Investigator: Jae Hui Kim, M.D., Kim's Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-09-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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