ABSTRACT
Background. Pathologic myopia is one of the most common causes of legal blindness in developed countries. Myopic choroidal neovascularization (mCNV) is the most severe complication of pathologic myopia and anti-VEGF therapy, particularly represented by two molecules known as Ranibizumab and Aflibercept, is actually the gold standard treatment.
Purpose. This is the first project aiming to evaluate long-term efficacy and safety of anti-VEGF treatments in myopic choroidal neovascularization over ten-year extended follow-up and providing functional and anatomical information under exhaustive prognostic factors¿ analysis.
Design. Retrospective, observational study
Methods. The present study will be conducted on all patients with a diagnosis of myopic choroidal neovascularization with a minimum follow-up of ten years. All participants will be subjected to a comprehensive clinical and instrumental ophthalmological evaluation to complete the follow-up time, including: Best Corrected Visual Acuity (BCVA) measurement, Spectral Domain Optical Coherence Tomography (SD-OCT), fundus photography and fluorescein angiography (FA). The following variables will be studied: age, axial length, lens status, CNV localization, number and types of intravitreal anti-VEGF injections, LogMAR BCVA, CNV max height and size, complete/incomplete CNV regression, retinal and choroidal thickness maps at central 1-mm subfield (CSF), 3-mm and 6-mm areas of two peripheral rings from central point thickness (CPT). All patients were treated at baseline with 1 single Aflibercept or Ranibizumab injection and then evaluated and treated under pro-re nata (PRN) schedule based on anatomical and functional outcomes over the whole follow-up.
Results. Participants will be retrospectively evaluated by studying the associations and correlations between qualitative and quantitative data on prognostic factors over time, together with an efficacy and safety comparative study among employed anti-VEGF agents.
This is the first project in Literature to evaluate the outcomes of anti-VEGF agents in myopic CNV over such an extended follow-up. Our objective is to study the efficacy and the safety of anti-VEGF therapies after a prolonged p.r.n. use, and consequently to highlight their potential to influence the condition course. Specifically, we want to monitor the main prognostic factors and related anatomical and functional outcomes under intravitreal injections over time. This study is directed to analyze a large panel of variables: age, axial length, lens status, baseline BCVA logMAR, CNV size, CNV localization, choroidal thickness, macular chorioretinal atrophy size, complete/incomplete CNV regression, possible subretinal hemorrhage, number of injections and central foveal thickness. To date, there is no Literature on such long-term follow up of intravitreal injections of anti-VEGF drugs in myopic choroidal neovascularization and on such an exhaustive factors¿ evaluation. The strength of the present research project lies in its practical utility in assessing the optimal tailored therapy for myopic CNV through drug comparison and careful monitoring of any changes in prognostic factors over an extended follow-up time.