Choroidal Morphology Changes After Aflibercept Therapy in Pachychoroid Neovasculopathy

December 14, 2022 updated by: Jae Hui Kim, Kim's Eye Hospital
In the present study, investigators attempt to evaluate the short-term, detailed changes in choroidal morphology after three monthly injections of aflibercept in pachychoroid neovasculopathy. The association between these changes and clinical outcomes will be additionally investigated. The primary purpose of this study is to provide reference data regarding the aflibercept-related morphologic changes that implicate structural and functional choroidal alteration, and hence its clinical implications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pachychoroid neovasculopathy (PNV), is a recently proposed entity after advancements in retinal imaging, belonging to the pachychoroid spectrum of diseases. It is a prevalent subtype of neovascular age-related macular degeneration (AMD) in the Asian population (19.5%~41.6% among neovascular AMD), characterized by presence of type 1 macular neovascularization (MNV) without polypoidal lesion in an eye exhibiting pachychoroid features, although its pathogenesis is not fully understood. In addition, PNV can be distinguished from typical neovascular AMD by a relative absence of drusen or pseudodrusen, younger age of onset, and thickened choroid with pachyvessels. Although both neovascular AMD and PNV respond well to anti-vascular endothelial growth factor (VEGF) therapy, separate analysis of treatment outcomes in PNV merits further investigation targeting the different underlying pathologies.

It is well-known that anti-VEGF therapy influences choroidal structures, including choroidal thickness, choroidal vascularity index, and choroidal area. In general, decrease in choroidal thickness after aflibercept injection is more prominent than that after ranibizumab or bevacizumab injections. Some investigators postulated that this difference in the effect on choroid is responsible for the superior efficacy of aflibercept in polypoidal choroidal vasculopathy (PCV) over other anti-VEGF agents and influence the choice of anti-VEGF agent in real-world practice. To date, several investigators have demonstrated changes in choroidal thickness after anti-VEGF therapy in PNV. However, the detailed changes in choroidal morphology after aflibercept therapy and its clinical implications in pachychoroidal neovasculopathy remain to be elucidated.

In the present study, investigators attempt to evaluate the short-term, detailed changes in choroidal morphology after three monthly injections of aflibercept in pachychoroid neovasculopathy. The association between these changes and clinical outcomes will be additionally investigated. The primary purpose of this study is to provide reference data regarding the aflibercept-related morphologic changes that implicate structural and functional choroidal alteration, and hence its clinical implications.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

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

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing, committed, and able to return for all clinic visits and complete all study related procedures.
  • Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
  • Signed informed consent
  • Patients aged 50 years or older

  • Patients diagnosed with treatment naïve pachychoroid neovasculopathy

    • Diagnostic criteria of PNV

      1. Presence of type 1 MNV
      2. Subfoveal choroidal thickness ≥250 µm
      3. Focal or diffuse choroidal thickening
      4. Presence of dilated choroidal vessels (pachyvessels)
      5. Thinning or absence of choriorapillaris and Sattler's layer overlying pachyvessels
      6. Absence of drusen or pseudodrusen, except for pachydrusen
  • ETDRS BCVA letter score ≥25 letters (approximately 20/320 or better) in the study eye

Exclusion Criteria:

  • Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
  • Prior treatment with anti-VEGF agents
  • Known serious allergy to the fluorescein sodium for injection in angiography.
  • Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
  • Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  • Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  • Any history of uveitis in either eye.
  • Presence of definite chorioretional anastomosis
  • Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible choroidal neovascularization.)
  • Scar or fibrosis, making up > 50% of total lesion in the study eye.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
  • Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.
  • Prior vitrectomy in the study eye
  • Any history of macular hole of stage 2 and above in the study eye.
  • Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
  • Prior trabeculectomy or other filtration surgery in the study eye.
  • Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  • Active intraocular inflammation in either eye.
  • Active ocular or periocular infection in either eye.
  • Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet posterior capsulotomy) in the study eye.
  • History of corneal transplant or corneal dystrophy in the study eye.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflibercept treatment group
Patients receiving three monthly aflibercept injections
Drug: Three monthly injections of intravitreal aflibercept
Three monthly intravitreal injection of aflibercept (2.0mg / 0.05ml) after diagnosis of pathychoroid neovasculopathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of choroidal layer
Time Frame: Baseline and Week 12
Change in the area of each choroidal layer from baseline to week 12. The area will be assessed based on optical coherence tomography (OCT) image.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subfoveal choroidal thickness
Time Frame: Baseline and Week 12
Changes in subfoveal choroidal thickness from baseline to week 12. The thickness will be assessed based on OCT image
Baseline and Week 12
Largest choroidal vessel diameter
Time Frame: Baseline and Week 12
Changes in the largest choroidal vessel diameter from baseline to week 12. The diameter will be assessed based on OCT image
Baseline and Week 12
Choroidal vascularity index (CVI)
Time Frame: Baseline and Week 12
Changes in choroidal vascularity index from baseline to week 12. The CVI will be assessed based on OCT image
Baseline and Week 12
Lesion size
Time Frame: Baseline and Week 12
Changes in lesion size on OCT-angiography from baseline to week 12. The lesion size will be assessed based on OCT angiography image
Baseline and Week 12
Best-corrected visual acuity (BCVA)
Time Frame: Baseline and Week 12
Changes in BCVA from baseline to week 12. The BCVA will be assessed using manifest refraction with early treatment of diabetic retinopathy score chart
Baseline and Week 12
Fluid after loading injections
Time Frame: Baseline and Week 12
Resolution of fluid after loading injections from baseline to week 12. The resolution will be assessed based on OCT image
Baseline and Week 12
Choroidal morphology changes
Time Frame: Baseline and Week 12
Difference in choroidal morphology changes between patients with and without fluid resolution. The morphology changes will be assessed based on OCT image
Baseline and Week 12
Central retinal thickness
Time Frame: Baseline and Week 12
Changes in central retinal thickness (CRT) from baseline to week 12. The CRT will be assessed based on OCT image.
Baseline and Week 12

Collaborators and Investigators

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

Sponsor

Kim's Eye Hospital

Collaborators

Nune Eye Hospital, Seoul, Korea
HanGil Eye Hospital

Investigators

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

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 (Anticipated)

December 26, 2022

Primary Completion (Anticipated)

June 26, 2023

Study Completion (Anticipated)

December 26, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Estimate)

December 22, 2022

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-10-001

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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