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Photodynamic and Pharmacologic Treatment of CNV (PBS)

Primary Purpose

Choroidal Neovascularization, Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
verteporfin (Visudyne)
ranibizumab (Lucentis)
Sponsored by
Mid-Atlantic Retina Consultations, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Neovascularization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All previously untreated CNV secondary to MD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    I

    II

    Arm Description

    Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)

    Treatment with ranibizumab (Lucentis)

    Outcomes

    Primary Outcome Measures

    Visual change

    Secondary Outcome Measures

    Frequency of treatment

    Full Information

    First Posted
    December 6, 2007
    Last Updated
    July 6, 2012
    Sponsor
    Mid-Atlantic Retina Consultations, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00570193
    Brief Title
    Photodynamic and Pharmacologic Treatment of CNV
    Acronym
    PBS
    Official Title
    Photodynamic and Pharmacologic Treatment of Choroidal Neovascularization (Photodynamic Booster Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mid-Atlantic Retina Consultations, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The goal of this pilot study is to validate the use of the combination of Lucentis (ranibizumab) and Visudyne (verteporfin) in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) and to explore the use of a volumetric analysis of the CNV lesion to determine disease activity, response to therapy, and as a tool for determining the need for retreatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choroidal Neovascularization, Macular Degeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I
    Arm Type
    Experimental
    Arm Description
    Combined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
    Arm Title
    II
    Arm Type
    Experimental
    Arm Description
    Treatment with ranibizumab (Lucentis)
    Intervention Type
    Drug
    Intervention Name(s)
    verteporfin (Visudyne)
    Other Intervention Name(s)
    Visudyne = verteporfin, Lucentis = ranibizumab
    Intervention Description
    Verteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
    Intervention Type
    Drug
    Intervention Name(s)
    ranibizumab (Lucentis)
    Other Intervention Name(s)
    Lucentis = ranibizumab
    Intervention Description
    ranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33&37 per study protocol
    Primary Outcome Measure Information:
    Title
    Visual change
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Frequency of treatment
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All previously untreated CNV secondary to MD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nabil M Jabbour, MD
    Organizational Affiliation
    Mid-Atlantic Retina Consultations
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Photodynamic and Pharmacologic Treatment of CNV

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