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

Study Overview
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Brief Summary
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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.

Conditions
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Neovascular Age Related Macular Degeneration

Intervention / Treatment
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* Other: PDT plus intravitreal triamcinolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cnv secondary to age related macular degeneration Exclusion Criteria: glaucoma, diabetic retinopathy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PDT plus intravitreal triamcinolone|PDT plus intravitreal triamcinolone|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1, Week 1, 4 and 12 | 
| 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. | Day 1, week 1, 4 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVTA; CNV; age-related macular degeneration; PDT