Deep Learning-Based OCTA Quantification and Modeling for Predicting Long-Term Anti-VEGF Efficacy in mCNV

Обзор

Myopic choroidal neovascularization (mCNV) is one of the sight-threatening complications secondary to pathological myopia. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) is its first-line therapy. However, mCNV is prone to recurrence and long-term visual decline, and there is currently no definitive method for predicting long-term prognosis. This project aims to conduct a long-term follow-up and multi-dimensional quantitative analysis of mCNV using optical coherence tomography angiography (OCTA) images. It seeks to evaluate long-term prognostic indicators, such as recurrence and long-term visual acuity, following anti-VEGF therapy for mCNV, and to construct a deep learning (DL) prediction model for anti-VEGF efficacy based on multi-modal clinical data, ultimately enabling treatment personalization. First, deep learning technology will be utilized to segment and quantitatively analyze mCNV in OCTA images, obtaining multi-dimensional quantitative parameters. These include OCTA-based The mCNV area and vessel junction(VJ). Patients will be followed up regularly for two years post-treatment, monitoring the number of injections, mCNV recurrence, OCT and OCTA quantitative parameters, fundus chorioretinal atrophy lesions, and visual acuity status. A multi-modal DL prediction model will be constructed, primarily based on the multi-dimensional quantitative characteristics of mCNV from OCTA images. This model will aim to identify sensitive indicators for predicting best-corrected visual acuity and recurrence after anti-VEGF therapy for mCNV and to clarify the relationship between therapeutic efficacy, baseline lesion status, and treatment regimen selection. This research will open new avenues for clinically assessing the long-term efficacy of anti-VEGF therapy for mCNV, significantly improve the efficiency and accuracy of efficacy evaluation, and provide a critical reference for personalizing anti-VEGF treatment plans, holding substantial clinical significance.

Вмешательства

• Другое No interventions beyond routine medical care
  No interventions beyond routine medical care

Первичные конечные точки

• Change in Best-Corrected Visual Acuity at 24 Months [Срок оценки: Baseline to 24 months]
• Number of Recurrence Events During 24-Month Follow-up [Срок оценки: Baseline to 24 months]

Вторичные конечные точки (2)

• Change in Myopic Choroidal Neovascularization Area at 24 Months [Срок оценки: Baseline to 24 months]
• Change In Number of Vessel Junctions at 24 Months [Срок оценки: Baseline to 24 months]

Критерии участия

Критерии включения

• Myopic spherical equivalent greater than -6.0 diopters and/or axial length > 26.5 mm.
• Patients presenting with myopic fundus changes, as defined by the International Photographic Classification System for Myopic Maculopathy.
• Completion of a comprehensive ophthalmic examination at initial diagnosis, including Best Corrected Visual Acuity , slit-lamp examination, dilated fundus examination, intraocular pressure measurement, refractometry, axial length measurement, color fundus photography, Optical Coherence Tomography, OCT Angiography, and Fundus Fluorescein Angiography.
• Patients with active mCNV at initial diagnosis who are treatment-naïve.
• Final inclusion of all images required confirmation by two retinal specialists. Images with discrepant assessments were adjudicated by a senior researcher to reach a final decision.

Критерии исключения

• Patients with choroidal neovascularization (CNV) due to causes other than myopia, such as age-related macular degeneration, adult-onset foveomacular vitelliform dystrophy, multifocal choroiditis, punctate inner choroidopathy, or retinoschisis.
• Poor-quality OCTA images, for example, those containing projection artifacts from overlying vessels at the mCNV lesion site, or excessively dark images dominated by thick outer choroidal vessels.
• Patients with a history of intraocular surgery, such as prior pars plana vitrectomy.
• Subjects who developed any of the above conditions during the follow-up period or who requested to withdraw from the study were removed from the experimental cohort.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Yang HS, Kim JG, Kim JT, Joe SG. Prognostic factors of eyes with naive subfoveal myopic choroidal neovascularization after intravitreal bevacizumab. Am J Ophthalmol. 2013 Dec;156(6):1201-1210.e2. doi: 10.1016/j.ajo.2013.08.002. Epub 2013 Sep 25. PMID 24075429
• Wang Y, Hu Z, Zhu T, Su Z, Fang X, Lin J, Chen Z, Su Z, Ye P, Ma J, Zhang L, Li J, Feng L, Sun CB, Zhang Z, Shentu X. Optical Coherence Tomography Angiography-Based Quantitative Assessment of Morphologic Changes in Active Myopic Choroidal Neovascularization During Anti-vascular Endothelial Growth Factor Therapy. Front Med (Lausanne). 2021 May 7;8:657772. doi: 10.3389/fmed.2021.657772. eCollection PMID 34026789
• Hosoda Y, Miyata M, Uji A, Ooto S, Yamashiro K, Tamura H, Oishi A, Ueda-Arakawa N, Miyake M, Hata M, Muraoka Y, Takahashi A, Tsujikawa A. Novel Predictors of Visual Outcome in Anti-VEGF Therapy for Myopic Choroidal Neovascularization Derived Using OCT Angiography. Ophthalmol Retina. 2018 Nov;2(11):1118-1124. doi: 10.1016/j.oret.2018.04.011. Epub 2018 May 31. PMID 31047549
• Miyata M, Ooto S, Hata M, Yamashiro K, Tamura H, Akagi-Kurashige Y, Nakanishi H, Ueda-Arakawa N, Takahashi A, Kuroda Y, Wakazono T, Yoshikawa M, Yoshimura N. Detection of Myopic Choroidal Neovascularization Using Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 May;165:108-14. doi: 10.1016/j.ajo.2016.03.009. Epub 2016 Mar 10. PMID 26973049
• Rocholz R, Corvi F, Weichsel J, Schmidt S, Staurenghi G. OCT Angiography (OCTA) in Retinal Diagnostics. 2019 Aug 14. In: Bille JF, editor. High Resolution Imaging in Microscopy and Ophthalmology: New Frontiers in Biomedical Optics [Internet]. Cham (CH): Springer; 2019. Chapter 6. Available from http://www.ncbi.nlm.nih.gov/books/NBK554041/ PMID 32091844
• Li S, Sun L, Zhao X, Huang S, Luo X, Zhang A, Chen C, Wang Z, Liu C, Ding X. ASSESSING THE ACTIVITY OF MYOPIC CHOROIDAL NEOVASCULARIZATION: Comparison Between Optical Coherence Tomography Angiography and Dye Angiography. Retina. 2020 Sep;40(9):1757-1764. doi: 10.1097/IAE.0000000000002650. PMID 31652198
• Zhu Y, Zhang T, Xu G, Peng L. Anti-vascular endothelial growth factor for choroidal neovascularisation in people with pathological myopia. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD011160. doi: 10.1002/14651858.CD011160.pub2. PMID 27977064
• Soubrane G. Choroidal neovascularization in pathologic myopia: recent developments in diagnosis and treatment. Surv Ophthalmol. 2008 Mar-Apr;53(2):121-38. doi: 10.1016/j.survophthal.2007.12.004. PMID 18348878

Идентификаторы

NCT: NCT07402629 · 2025-1039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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