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.