Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia
Condition: Myopia, Degenerative
MeSH terms: Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): PDT standard fluence, ranibizumab; PDT reduced fluence, ranibizumab; ranibizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Photodynamic therapy; Photodynamic therapy; Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment