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

NCT07402629 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1039
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myopic Choroidal Neovascularization

Keywords

Deep learning

Outcome Measures

Primary Outcomes (2)

• Change in Best-Corrected Visual Acuity at 24 Months

  This outcome evaluates the change in best-corrected visual acuity (BCVA) from baseline to 24 months in eyes with myopic choroidal neovascularization receiving intravitreal anti-vascular endothelial growth factor treatment as part of routine clinical care. BCVA reflects functional visual outcome and is measured at each visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart under standardized testing conditions. BCVA values are recorded as ETDRS letter scores, and the primary assessment is the within-eye change from baseline to the 24-month follow-up visit.

  Baseline to 24 months

• Number of Recurrence Events During 24-Month Follow-up

  This outcome assesses disease activity by quantifying the number of recurrence events during the 24-month follow-up period in eyes with myopic choroidal neovascularization treated with intravitreal anti-vascular endothelial growth factor therapy. Recurrence is defined as the reappearance of active myopic choroidal neovascularization following an initial treatment response, as determined by clinical examination and imaging findings, including evidence of lesion activity that necessitates additional anti-vascular endothelial growth factor treatment.

  Baseline to 24 months

Secondary Outcomes (2)

• Change in Myopic Choroidal Neovascularization Area at 24 Months

  Baseline to 24 months

• Change In Number of Vessel Junctions at 24 Months

  Baseline to 24 months

Study Arms (1)

Treatment-naïve patients with active mCNV at initial diagnosis, scheduled for intravitreal anti-VEGF

Other: No interventions beyond routine medical care

Interventions

No interventions beyond routine medical care OTHER

No interventions beyond routine medical care

Treatment-naïve patients with active mCNV at initial diagnosis, scheduled for intravitreal anti-VEGF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with initially diagnosed, treatment-naïve active mCNV who are scheduled to undergo intravitreal anti-VEGF injection.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Related Publications (10)

• 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 RESULT

• 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 2021.

  PMID: 34026789 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Wong TY, Ferreira A, Hughes R, Carter G, Mitchell P. Epidemiology and disease burden of pathologic myopia and myopic choroidal neovascularization: an evidence-based systematic review. Am J Ophthalmol. 2014 Jan;157(1):9-25.e12. doi: 10.1016/j.ajo.2013.08.010. Epub 2013 Oct 5.

  PMID: 24099276 RESULT

• Mi L, Zuo C, Zhang X, Liu B, Peng Y, Wen F. Fluorescein Leakage within Recent Subretinal Hemorrhage in Pathologic Myopia: Suggestive of CNV? J Ophthalmol. 2018 Aug 13;2018:4707832. doi: 10.1155/2018/4707832. eCollection 2018.

  PMID: 30186627 RESULT

Central Study Contacts

Yao Wang 王

CONTACT

+8613968028750; wangyao@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 11, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share