Choroidal Morphology Changes After Aflibercept Therapy in Pachychoroid Neovasculopathy

NCT05662410 | Completed Phase 4

• 1 other identifier: 2022-10-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pachychoroid Neovasculopathy

Keywords

Pachychoroid neovasculopathy; Aflibercept; Choroidal morphology

Outcome Measures

Primary Outcomes (1)

• Area of choroidal layer

  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 Outcomes (8)

• Subfoveal choroidal thickness

  Baseline and Week 12

• Largest choroidal vessel diameter

  Baseline and Week 12

• Choroidal vascularity index (CVI)

  Baseline and Week 12

• Lesion size

  Baseline and Week 12

• Best-corrected visual acuity (BCVA)

  Baseline and Week 12

Study Arms (1)

Aflibercept treatment group

EXPERIMENTAL

Patients receiving three monthly aflibercept injections

Drug: Three monthly injections of intravitreal aflibercept

Interventions

Three monthly injections of intravitreal aflibercept DRUG

Three monthly intravitreal injection of aflibercept (2.0mg / 0.05ml) after diagnosis of pathychoroid neovasculopathy.

Aflibercept treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kim's Eye Hospital: lead
• Nune Eye Hospital, Seoul, Korea: collaborator
• HanGil Eye Hospital: collaborator

Study Sites (1)

Jae Hui Kim

Seoul, 150-034, South Korea

Location

Related Publications (7)

• Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331.

  PMID: 25158945 BACKGROUND

• Cheung CMG, Lee WK, Koizumi H, Dansingani K, Lai TYY, Freund KB. Pachychoroid disease. Eye (Lond). 2019 Jan;33(1):14-33. doi: 10.1038/s41433-018-0158-4. Epub 2018 Jul 11.

  PMID: 29995841 BACKGROUND

• Pellegrini M, Bernabei F, Mercanti A, Sebastiani S, Peiretti E, Iovino C, Casini G, Loiudice P, Scorcia V, Giannaccare G. Short-term choroidal vascular changes after aflibercept therapy for neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2021 Apr;259(4):911-918. doi: 10.1007/s00417-020-04957-5. Epub 2020 Oct 13.

  PMID: 33048236 BACKGROUND

• Kim JH, Lee TG, Chang YS, Kim CG, Cho SW. Short-term choroidal thickness changes in patients treated with either ranibizumab or aflibercept: a comparative study. Br J Ophthalmol. 2016 Dec;100(12):1634-1639. doi: 10.1136/bjophthalmol-2015-308074. Epub 2016 Mar 7.

  PMID: 26951770 BACKGROUND

• Padron-Perez N, Arias L, Rubio M, Lorenzo D, Garcia-Bru P, Catala-Mora J, Caminal JM. Changes in Choroidal Thickness After Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Pachychoroid Neovasculopathy. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):1119-1124. doi: 10.1167/iovs.17-22144.

  PMID: 29490349 BACKGROUND

• Schworm B, Luft N, Keidel LF, Kreutzer TC, Herold TR, Priglinger SG, Siedlecki J. Vanishing pachy-choroid in pachychoroid neovasculopathy under long-term anti-vascular endothelial growth factor therapy. BMC Ophthalmol. 2021 Jun 30;21(1):269. doi: 10.1186/s12886-021-02022-1.

  PMID: 34193089 BACKGROUND

• Jung BJ, Kim JY, Lee JH, Baek J, Lee K, Lee WK. Intravitreal aflibercept and ranibizumab for pachychoroid neovasculopathy. Sci Rep. 2019 Feb 14;9(1):2055. doi: 10.1038/s41598-019-38504-y.

  PMID: 30765771 BACKGROUND

Study Officials

• Jae Hui H Kim, M.D.

  Kim's Eye Hospital, South Korea

  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: Principle Investigator

Model Details: Three monthly injections of intravitreal aflibercept during the first 3 months.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: December 26, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 26, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)