Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia: 48 Weeks Study Results
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- Mean change in best-corrected visual acuity (BCVA) from baseline
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: PDT standard fluence, ranibizumab (Drug)
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
Intervention: PDT reduced fluence, ranibizumab (Drug)
ranibizumab
0.5 mg (10 mg/ml) intravitreal ranibizumab.
Intervention: ranibizumab (Drug)
Outcomes
Primary Outcomes
Mean change in best-corrected visual acuity (BCVA) from baseline
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Chiosi Flavia
MD
University of Campania "Luigi Vanvitelli"