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

Phase 3

Completed

• Conditions: Neovascular Age Related Macular Degeneration

• Registration Number: NCT00685100
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2006-01
• Study Completion: 2007-01
• Status Verified: 2008-05
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• cnv secondary to age related macular degeneration

Exclusion Criteria

• glaucoma, diabetic retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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