NEWS HIGHLIGHTS
Published Studies Related to Visudyne (Verteporfin)
Improvement in multifocal electroretinography after half-dose verteporfin photodynamic therapy for central serous chorioretinopathy: a randomized placebo-controlled trial. [2011.07]
PURPOSE: To evaluate retinal functional changes by multifocal electroretinography (mfERG) after photodynamic therapy with half-dose verteporfin in patients with acute central serous chorioretinopathy... CONCLUSIONS: Multifocal electroretinography demonstrated higher retinal function at the central macula objectively in central serous chorioretinopathy patients treated with half-dose verteporfin photodynamic therapy. Changes in best-corrected visual acuity and optical coherence tomography central foveal thickness findings also correlated with mfERG responses of the central macula, confirming the usefulness of mfERG as an objective investigation to evaluate the functional changes in central serous chorioretinopathy.
IMPROVEMENT IN MULTIFOCAL ELECTRORETINOGRAPHY AFTER HALF-DOSE VERTEPORFIN PHOTODYNAMIC THERAPY FOR CENTRAL SEROUS CHORIORETINOPATHY: A Randomized Placebo-Controlled Trial. [2011.03.03]
PURPOSE:: To evaluate retinal functional changes by multifocal electroretinography (mfERG) after photodynamic therapy with half-dose verteporfin in patients with acute central serous chorioretinopathy... CONCLUSIONS:: Multifocal electroretinography demonstrated higher retinal function at the central macula objectively in central serous chorioretinopathy patients treated with half-dose verteporfin photodynamic therapy. Changes in best-corrected visual acuity and optical coherence tomography central foveal thickness findings also correlated with mfERG responses of the central macula, confirming the usefulness of mfERG as an objective investigation to evaluate the functional changes in central serous chorioretinopathy.
An observational retrospective subgroup analysis of verteporfin photodynamic therapy-naive and previously treated patients in the focus trial. [2011.01]
PURPOSE: To perform a retrospective post hoc subgroup analysis of the FOCUS trial to assess the visual acuity outcomes and treatment benefits for patients receiving combination therapy who, at the time of enrollment, were naive to verteporfin photodynamic therapy (PDT) or had previously received PDT... CONCLUSION: In the FOCUS subanalysis, the PDT-naive patients showed a trend toward greater treatment benefit over control subjects compared with patients previously treated with PDT. However, this study was not designed to address this question, and the confidence intervals were wide. Furthermore, the mean change in the visual acuity from baseline to 24 months was similar for both the PDT-naive and previously treated patients receiving combination therapy.
Verteporfin photodynamic therapy cohort study: report 3: cost effectiveness and lessons for future evaluations. [2009.12]
PURPOSE: To report (1) the costs of verteporfin photodynamic therapy (VPDT) in routine treatment of neovascular age-related macular degeneration (nAMD), (2) the relationship between health and social service costs and best-corrected visual acuity (BCVA), (3) the cost-effectiveness of VPDT versus a best supportive care (BSC) group who were assumed to have no active treatment, and (4) lessons for future cost-effectiveness analyses (CEAs). DESIGN: The CEA of VPDT versus BSC that uses health-related quality of life (HrQoL), resource use, and visual acuity data from the United Kingdom (UK) VPDT Cohort Study. PARTICIPANTS: Data on VPDT use were collected from patients attending 45 ophthalmology provider units in the UK National Health Service, 15 units collected data on self-reported use of services... CONCLUSIONS: Verteporfin photodynamic therapy is unlikely to be cost effective for patients with nAMD. This article provides realistic estimates of VPDT costs and the costs associated with declining vision. Future studies can follow this approach to assess accurately the cost effectiveness of new interventions for nAMD.
Verteporfin photodynamic therapy cohort study: report 2: clinical measures of vision and health-related quality of life. [2009.12]
PURPOSE: To quantify decreases in health-related quality of life (HRQoL) for given deterioration in clinical measures of vision; to describe the shape of these relationships; and to test whether the gradients of these relationships change with duration of visual loss. DESIGN: A prospective, longitudinal study of patients treated with verteporfin photodynamic therapy in the United Kingdom National Health Service. PARTICIPANTS: Patients with neovascular age-related macular degeneration (AMD) treated in 18 ophthalmology departments in the United Kingdom with expertise in management of neovascular AMD... CONCLUSIONS: Clinically significant deterioration in clinical measures of vision is associated with small decreases in generic and vision-specific HRQoL. Our findings are important for further research modeling the cost effectiveness of current and future interventions for neovascular AMD.
Clinical Trials Related to Visudyne (Verteporfin)
Phase II Pilot Study of Visudyne� Photodynamic Therapy (PDT) (Low and Very Low Fluence) Combined With Bevacizumab. [Completed]
To determine if Visudyne photodynamic therapy (low or very low fluence rate) combined with
intravitreal injections of bevacizumab (Avastin) compared with bevacizumab alone will, with
similar safety and efficacy, delay time to retreatment with bevacizumab after the initial
treatment, in subjects with new wet AMD Hypothesis: PDT in combination with Avastin at
either the low or very low fluence rate will delay time to retreatment and reduce the
average number of treatments required, compared to Avastin alone, but will have a similar
safety and efficacy profile.
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL) [Completed]
The objective of this study is to determine if combination therapy (reduced-fluence Visudyne
followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne
followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment
rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an
acceptable safety profile.
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization [Completed]
This study evaluated the effect of combination therapy with verteporfin photodynamic therapy
and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy
and the durability of response observed in patients with choroidal neovascularization
secondary to age-related macular degeneration.
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib [Completed]
To evaluate the safety and efficacy of the combination treatments in wet age-related macular
degeneration. The combination treatment consists of verteporfin photodynamic therapy and
either triamcinolone acetonide or pegaptanib added as an intravitreal injection.
Bevacizumab in Combination With Visudyne Photodynamic Therapy (PDT) [Completed]
To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage,
and the number of treatments of combination intravitreal bevacizumab and verteporfin
photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due
to age-related macular degeneration.
Reports of Suspected Visudyne (Verteporfin) Side Effects
Visual Acuity Reduced (14),
Retinal Haemorrhage (10),
Choroidal Neovascularisation (10),
Retinal Pigment Epithelial Tear (9),
Retinal Detachment (8),
Choroidal Dystrophy (7),
Disease Recurrence (5),
AGE-Related Macular Degeneration (4),
Eye Infection Toxoplasmal (4),
Blindness (4), more >>
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