NCT01968486

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

Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia: 48 Weeks Study Results

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia, Degenerative

Interventions

Type	Name	Description
DRUG	PDT standard fluence, ranibizumab	In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT standard fluence (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 mW/cm2 for 83 s). Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.
DRUG	PDT reduced fluence, ranibizumab	In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT reduced fluence ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s).Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.
DRUG	ranibizumab	In the ranibizumab monotherapy arm patients were treated with a loading phase of three consecutive 0.5 mg (10 mg/ml) IVR injections every six weeks. Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid \> 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-10-24
• Last updated: 2013-10-28