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Starting soon Observational

The Treatment Burden of Myopic Choroidal Neovascularization

NCT07009574 · tracked via the Priya Life Science Italy tracker
Sponsor
Policlinico Gaspare Rodolico - San Marco Catania
Phase
Observational
Started
2025-06-01
Last updated
2025-06-06

Condition(s) studied

Myopic Choroidal NeovascularisationAnti-VEGF TreatmentBurden

Investigational drug(s) / intervention(s)

anti-VEGF intravitreal treatment in patients affected by myopic choroidal neovascularization

anti-VEGF intravitreal treatment in patients affected by myopic choroidal neovascularization: All patients underwent one intravitreal injection at baseline (0.5 mg ranibizumab or 2.0 mg aflibercept); additional intravitreal injections were administered over the follow-up period based on the above-mentioned activity signs with a pro-re-nata (PRN) treatment protocol. The patients have been followed on a monthly or bimonthly basis. The number of visits and examinations in the 12-month study period will be collected. Clinical and imaging data of the baseline examination as well as of the 12-month visit (M12) after the first intravitreal injection.

Study summary

Pathologic myopia (PM) is characterized by progressive eye elongation associated with degenerative changes in the retinal and choroidal tissue. Myopic choroidal neovascularization (mCNV) is a well-known complication of PM, occurring in 5-11% of cases and representing a main cause of visual impairment in working people under the age of 50.

The management of patients affected by active mCNV have been revolutionized by the advent of intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs.

Patients affected by mCNV needs intravitreal injections and visits to assess the need of retreatment with assiduity. It represents a significant burden for patients, caregivers as well as medical equipe.

The aim of this study is to investigate the factors associated with the number of anti-VEGF injections and hospital visits necessary to get mCNV disease stabilization and to identify predictive factors of treatment burden.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * axial length\>26 mm or refractive error (spherical equivalent) \<-6 Diopters * clinical changes typical of Pathologic myopia * diagnosis of subfoveal or juxtafoveal treatment-naïve myopic choroidal neovascularization (mCNV) * only one eye per patient was included in the analysis, in cases of patients treated bilaterally only the first eye treated was included Exclusion Criteria: * Extrafoveal mCNV location * Other retinal diseases * any inflammatory condition which may cause CNV including multifocal choroiditis, puntate inner choroidopathy and white dot syndrome * previous ocular surgery (except for cataract extraction performed before the baseline visit) * inferior quality imaging

Primary outcome measure(s)

  • To assess treatment burden — one year
    The number of access of the patient to the hospital for any clinical need (intravitreal injections administration, imaging examinations and visits) in the first year of anti-VEGF treatment.

Trial sites (1)

FacilityCityRegionStatus
Policlinico Rodolico Catania Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009574 on ClinicalTrials.gov ↗ ← All trials in Italy