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Visudyne (Verteporfin) - Summary

 
 



VISUDYNE SUMMARY

VISUDYNE®
(VERTEPORFIN FOR INJECTION)
CC 070095-1

VISUDYNE® (verteporfin for injection) is a light activated drug used in photodynamic therapy.

VISUDYNE therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal choroidal neovascularization.


See all Visudyne indications & dosage >>

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.

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Clinical Trials Related to Visudyne (Verteporfin)

Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration [Recruiting]
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.

The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1: 1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U. S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD) [Terminated]
The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.

Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL) [Active, not recruiting]
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.

VisudyneŽ in Occult (VIO) [Completed]
The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization (CNV) lesions will, with an acceptable safety profile, significantly reduce the risk of vision loss compared with placebo (sham treatment).

Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-Based Retreatment [Recruiting]
This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).

The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.

The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.

more trials >>

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 >>


Page last updated: 2011-12-09

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