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OpenTrials
Completed

NCT Number: NCT00685100

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cnv secondary to age related macular degeneration

Exclusion criteria

  • glaucoma, diabetic retinopathy

Treatment and study plan

PDT plus intravitreal triamcinolone

Other

PDT plus intravitreal triamcinolone

Primary outcomes

  1. visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)

    Time frame: Day 1, Week 1, 4 and 12

    "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.

  2. visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)

    Time frame: Day 1, week 1, 4 and 12

    "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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
May 28, 2008
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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