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

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).

Study Overview

• Status: Completed
• Conditions: Myopia, Degenerative
• Intervention / Treatment: Drug: PDT standard fluence, ranibizumab; Drug: PDT reduced fluence, ranibizumab; Drug: ranibizumab

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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.; Other Names: Photodynamic therapy
EXPERIMENTAL: 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	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.; Other Names: Photodynamic therapy
EXPERIMENTAL: ranibizumab; 0.5 mg (10 mg/ml) intravitreal ranibizumab.	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.; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in best-corrected visual acuity (BCVA) from baseline	24 weeks

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Flavia Chiosi, MD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: October 19, 2013
• First Posted (ESTIMATE): October 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 28, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Refractive Errors; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Myopia; Myopia, Degenerative; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: fidelio