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
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
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
NCT ID
NCT00685100
First Posted
May 23, 2008
Last Updated
April 14, 2015
Sponsor
Medical University of Vienna
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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