Overview

Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia

Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
Summary
To demonstrate the efficacy of ranibizumab in combination with reduced-fluence verteporfin photodynamic therapy (RF-PDT) in patients with subfoveal choroidal neovascularization secondary to pathologic myopia (PM).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Second University of Naples
University of Campania "Luigi Vanvitelli"
Treatments:
Ranibizumab
Verteporfin
Criteria
Inclusion Criteria:

- pathologic myopia, defined as spherical equivalent greater than 6 D and axial length
more than 26 mm (Carl Zeiss IOLMaster V 4.07; Carl Zeiss Meditec, Dublin, California,
USA);

- posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy,
papillary crescent);

- fluorescein angiography (FA) detection of the subfoveal or juxtafoveal CNV (CNV was
classified as juxta-foveal if the lesion was closer than 200 mm but not under the
geometric center of the foveal avascular zone);

- clear ocular media;

- duration of symptoms no longer than 4 weeks before enrollment.

Exclusion Criteria:

- prior treatment for CNV including previous intravitreal drugs injection or PDT-V;

- presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion;

- history of recent myocardial infarction or other thromboembolic events;

- ongoing uncontrolled hypertension or glaucoma;

- refractive media opacities;

- eye surgery.