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

Phase 1

Completed

• Conditions: Myopia, Degenerative
• Interventions: Drug: PDT standard fluence, ranibizumab; Drug: PDT reduced fluence, ranibizumab; Drug: ranibizumab

• Registration Number: NCT01968486
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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).

Detailed Description

Sixty patients received ranibizumab 0.5 mg combined with reduced fluence (RF) verteporfin PDT. Ranibizumab was first administered to patients followed after seven days by RF-PDT. Subsequently intravitreal ranibizumab (IVR) was injected as needed (pro re nata). All patients were evaluated every 4 weeks for 48 weeks.

Main Outcome Measures: Mean change in best-corrected visual acuity (BCVA) from baseline at 48 weeks, reduced mean central foveal thickness (CFT) analyzed by optical coherence tomography (OCT) and improved macular sensitivity registered at microperimetry (MP) evaluation.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2013-07-10
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-19
• Study First Posted: 2013-10-24
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDT Standard Fluence, ranibizumab	PDT standard fluence, ranibizumab	verteporfin (6 mg/m2) SF (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 milliwatt(mW)/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab
PDT Reduced Fluence, ranibizumab	PDT reduced fluence, ranibizumab	verteporfin (6 mg/m2) RF ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s) plus 0.5 mg intravitreal ranibizumab
ranibizumab	ranibizumab	0.5 mg (10 mg/ml) intravitreal ranibizumab.

Primary Outcome Measures

Name	Time	Method
Mean change in best-corrected visual acuity (BCVA) from baseline	24 weeks