drugset / Trial / NCT05662410
Choroidal Morphology Changes After Aflibercept Therapy in Pachychoroid Neovasculopathy
Phase 4
Completed
30 enrolled
Kim's Eye Hospital
HanGil Eye Hospital · collabNune Eye Hospital, Seoul, Korea · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-12-26
- Primary completion
- 2024-05-24
- Completion
- 2024-05-26
Publications
- Results Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 0.05 ml | Intravitreal |
| Subject | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |