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Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone

Primary Purpose

Neovascular Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PDT plus intravitreal triamcinolone
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring IVTA; CNV; age-related macular degeneration; PDT

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cnv secondary to age related macular degeneration

Exclusion Criteria:

  • glaucoma, diabetic retinopathy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
    "Changes in macular sensitivity after reduced fluence photodynamic therapy combined with intravitreal triamcinolone" Mean DLT decreased from 4.71 dB at baseline to 3.45 dB after 12 months in the SPDT + IVTA group (mean decrease 1.26 dB; p > 0.05) and from 5.42 dB to 4.92 dB in the RPDT + IVTA group (mean decrease 0.5 dB; p > 0.05). Absolute and relative scotoma sizes remained stable in both groups at 12 months (mean change 0 and -0.6 test-points; p > 0.05). Mean DLT values and absolute scotoma sizes correlated well with early and late leakage areas in FA (r = -0.45 to -0.80, p < 0.02). With regard to MS, RPDT + IVTA did not show significant benefits over SPDT + IVTA at 12 months. Macular sensitivity correlated well with angiographic outcomes.
    visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
    "Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study" Baseline characteristics were well balanced in both groups (p>0.05). At week 12, patients in group A had a mean loss of -3.7 letters compared with a gain of 3.4 letters in group B (p = 0.04, between both groups). Both treatment groups showed a similar course regarding CRT as well as MS (p>0.05). In 70% (14/20) of group A and 15% (3/20) of group B, a choroidal hypoperfusion in the area of treatment was observed after treatment (p<0.001). In 70% of group A and 55% of group B, a repeat treatment was indicated at week 12 (p = 0.55). At month 3, the rPDT+IVTA group showed a significantly better visual outcome, less alteration of the choroid and a trend for lower recurrence rate than the sPDT+IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2008
    Last Updated
    April 14, 2015
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00685100
    Brief Title
    Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    January 2006 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    5. Study Description

    Brief Summary
    Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA). Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neovascular Age Related Macular Degeneration
    Keywords
    IVTA; CNV; age-related macular degeneration; PDT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    PDT plus intravitreal triamcinolone
    Intervention Description
    PDT plus intravitreal triamcinolone
    Primary Outcome Measure Information:
    Title
    visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
    Description
    "Changes in macular sensitivity after reduced fluence photodynamic therapy combined with intravitreal triamcinolone" Mean DLT decreased from 4.71 dB at baseline to 3.45 dB after 12 months in the SPDT + IVTA group (mean decrease 1.26 dB; p > 0.05) and from 5.42 dB to 4.92 dB in the RPDT + IVTA group (mean decrease 0.5 dB; p > 0.05). Absolute and relative scotoma sizes remained stable in both groups at 12 months (mean change 0 and -0.6 test-points; p > 0.05). Mean DLT values and absolute scotoma sizes correlated well with early and late leakage areas in FA (r = -0.45 to -0.80, p < 0.02). With regard to MS, RPDT + IVTA did not show significant benefits over SPDT + IVTA at 12 months. Macular sensitivity correlated well with angiographic outcomes.
    Time Frame
    Day 1, Week 1, 4 and 12
    Title
    visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
    Description
    "Reduced fluence versus standard photodynamic therapy in combination with intravitreal triamcinolone: short-term results of a randomised study" Baseline characteristics were well balanced in both groups (p>0.05). At week 12, patients in group A had a mean loss of -3.7 letters compared with a gain of 3.4 letters in group B (p = 0.04, between both groups). Both treatment groups showed a similar course regarding CRT as well as MS (p>0.05). In 70% (14/20) of group A and 15% (3/20) of group B, a choroidal hypoperfusion in the area of treatment was observed after treatment (p<0.001). In 70% of group A and 55% of group B, a repeat treatment was indicated at week 12 (p = 0.55). At month 3, the rPDT+IVTA group showed a significantly better visual outcome, less alteration of the choroid and a trend for lower recurrence rate than the sPDT+IVTA group. Further follow-up of this study will provide information on long-term functional results and treatment durability.
    Time Frame
    Day 1, week 1, 4 and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: cnv secondary to age related macular degeneration Exclusion Criteria: glaucoma, diabetic retinopathy

    12. IPD Sharing Statement

    Learn more about this trial

    Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone

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