The Treatment Burden of Myopic Choroidal Neovascularization
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPoliclinico Gaspare Rodolico - San Marco Catania
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients affected by myopic choroidal neovascularization
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
anti-VEGF intravitreal treatment in patients affected by myopic choroidal neovascularization
DrugAll 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients affected by myopic choroidal neovascularization1 intervention
Trial outcomes
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.
Time frame
one yearSecondary outcomes
1
Visual Acuity
Visual acuity (logMAR)
Time frame
one year2
Intraretinal Cysts
Presence of intraretinal cysts detected by OCT
Time frame
one year3
Subretinal fluid
Presence of OCT subretinal fluid by OCT
Time frame
one year4
Subretinal fuzzy material
Presence of subretinal fuzzy material detected by OCT
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov
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