Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia
Primary Purpose
Myopia, Degenerative
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PDT standard fluence, ranibizumab
PDT reduced fluence, ranibizumab
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Degenerative
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
PDT Standard Fluence, ranibizumab
PDT Reduced Fluence, ranibizumab
ranibizumab
Arm Description
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
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
0.5 mg (10 mg/ml) intravitreal ranibizumab.
Outcomes
Primary Outcome Measures
Mean change in best-corrected visual acuity (BCVA) from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT01968486
First Posted
July 10, 2013
Last Updated
October 25, 2013
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT01968486
Brief Title
Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia
Official Title
Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia: 48 Weeks Study Results
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Degenerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDT Standard Fluence, ranibizumab
Arm Type
Experimental
Arm Description
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
Arm Title
PDT Reduced Fluence, ranibizumab
Arm Type
Experimental
Arm Description
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
Arm Title
ranibizumab
Arm Type
Experimental
Arm Description
0.5 mg (10 mg/ml) intravitreal ranibizumab.
Intervention Type
Drug
Intervention Name(s)
PDT standard fluence, ranibizumab
Other Intervention Name(s)
Photodynamic therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PDT reduced fluence, ranibizumab
Other Intervention Name(s)
Photodynamic therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in best-corrected visual acuity (BCVA) from baseline
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Chiosi, MD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Reduced-fluence Verteporfin Photodynamic Therapy Plus Ranibizumab for Choroidal Neovascularization in Pathologic Myopia
We'll reach out to this number within 24 hrs