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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDT Standard Fluence, ranibizumab | Experimental | 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 | Experimental | 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 | Experimental | 0.5 mg (10 mg/ml) intravitreal ranibizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDT standard fluence, ranibizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best-corrected visual acuity (BCVA) from baseline | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavia Chiosi, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
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|
|
| PDT reduced fluence, ranibizumab | Drug | 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. |
|
|
| ranibizumab | Drug | 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. |
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|
| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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