The Treatment Burden of Myopic Choroidal Neovascularization

NCT07009574 | Not Yet Recruiting

• 1 other identifier: IRB Catania number 09/2024/PAR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopic Choroidal Neovascularisation; Anti-VEGF Treatment; Burden

Keywords

mcnv; anti-vegf; myopic maculopathy; choroidal neovascularization; myopia

Outcome Measures

Primary Outcomes (1)

• To assess treatment burden

  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.

  one year

Secondary Outcomes (6)

• Visual Acuity

  one year

• Intraretinal Cysts

  one year

• Subretinal fluid

  one year

• Subretinal fuzzy material

  one year

• Subretinal fibrosis

  one year

Study Arms (1)

Patients affected by myopic choroidal neovascularization

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

Interventions

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

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.

Patients affected by myopic choroidal neovascularization

Eligibility Criteria

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

Study Population

Patients affected by myopic choroidal neovascularization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Gaspare Rodolico - San Marco Catania: lead

Study Sites (1)

Policlinico Rodolico

Catania, Italy, 95030, Italy

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Myopia

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Refractive Errors

Central Study Contacts

Niccolò Castellino, MD, PhD

CONTACT

+3903394906191; ncastellino7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 6, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 15, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

IT (1)