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

NCT00685100 | Completed Phase 3

• 1 other identifier: 002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

IVTA; CNV; age-related macular degeneration; PDT

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

PDT plus intravitreal triamcinolone OTHER

PDT plus intravitreal triamcinolone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cnv secondary to age related macular degeneration

You may not qualify if:

• glaucoma, diabetic retinopathy

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: January 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2007
• Last Updated: April 15, 2015

Record last verified: 2008-05