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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
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Degenerative

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 10, 2013
    Last Updated
    October 25, 2013
    Sponsor
    University of Campania "Luigi Vanvitelli"
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    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

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