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Comparison of Ranibizumab Monotherapy and Ranibizumab Combination Therapies in Recurrent or Persistent Choroidal Neovascularization Secondary to Age-related Macular Degeneration

2014-07-23 21:08:16 | BioPortfolio

Summary

Age-related macular degeneration (AMD) is by far the most common disorder in the group of irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process and severely compromises the highly developed functions of the macula, such as perception of details, central fixation, color vision, and reading ability. AMD-related visual impairment is associated with a loss of autonomy and quality of life. Current therapeutic approaches target vascular endothelial growth factor (VEGF), which has been identified as a main cytokine in the pathogenesis of nAMD. Ranibizumab, the fab-fragment of an antibody targeting VEGF is approved for the treatment of nAMD applied intravitreally in monthly intervals until the disease activity is stopped. However, a significant proportion of patients with nAMD suffer from persistent or recurring disease with the need of continuous anti-VEGF therapy over months and years, often leading to irreversible changes in the photoreceptor layer and the pigment epithelium.

Recent studies regarding the treatment of nAMD utilized different forms of therapies, combining photodynamic therapy with verteporfin (PDT) and ranibizumab, as well as therapeutic regimen containing steroids. Even though these studies did not provide evidence that combination therapies are superior to ranibizumab monotherapy, studies were only conducted with patients with previously untreated nAMD. Therefore, currently there is no alternative therapeutic approach for patients with recurrent or persistent form of nAMD after multiple treatments with ranibizumab monotherapy.

The purpose of this study is to assess the treatment effect of reduced fluence PDT and intravitreal ranibizumab versus intravitreal dexamethasone and ranibizumab versus intravitreal ranibizumab monotherapy in patients with persistent or recurrent choroidal neovascularization (CNV) due to AMD.

The investigators hypothesis is that these findings will offer new insights in the management of persistent or recurrent CNV secondary to AMD.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Age-Related Macular Degeneration

Intervention

Reduced fluence photodynamic therapy and intravitreal ranibizumab, Intravitreal dexamethasone and intravitreal ranibizumab, Intravitreal ranibizumab

Location

Department of Ophthalmology, Medical University of Vienna
Vienna
Austria
1090

Status

Not yet recruiting

Source

Medical University of Vienna

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:16-0400

Clinical Trials [1640 Associated Clinical Trials listed on BioPortfolio]

Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using reduced fluence compared to the standard fluence.

Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light...

Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab ...

Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, ...

Triple Therapy - PDT Plus IVD and Intravitreal Ranibizumab Versus Lucentis Monotherapy to Treat Age-Related Macular Degeneration

The purpose of this study is to compare triple therapy using Photodynamic therapy, intravitreal Dexamethasone and intravitreal Ranibizumab injections versus monotherapy with intravitreal R...

PubMed Articles [13737 Associated PubMed Articles listed on BioPortfolio]

Photodynamic therapy in combination with ranibizumab versus ranibizumab monotherapy for wet age-related macular degeneration: A systematic review and meta-analysis.

To evaluate the efficacy and safety between photodynamic therapy (PDT) combined with intravitreal ranibizumab (IVR) and ranibizumab monotherapy in treating wet age-related macular degeneration (AMD).

Long-term results of photodynamic therapy or ranibizumab for polypoidal choroidal vasculopathy in LAPTOP study.

We previously reported that ranibizumab performed better on visual prognosis than photodynamic therapy (PDT) in a Ranibizumab (ucentis) nd hotodynamic herapy n olypoidal choroidal vasculopathy (LAPTOP...

3-year-data of combined navigated laser photocoagulation (Navilas) and intravitreal ranibizumab compared to ranibizumab monotherapy in DME patients.

The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therap...

FIVE-YEAR OUTCOMES OF INTRAVITREAL RANIBIZUMAB FOR CHOROIDAL NEOVASCULARIZATION IN PATIENTS WITH PATHOLOGIC MYOPIA.

To determine the 5-year outcome of intravitreal ranibizumab (IVR) for myopic choroidal neovascularization (CNV).

XEN Gel Stent to Treat Intraocular Hypertension after Dexamethasone-implant Intravitreal Injections: 5 Cases.

Intravitreal injections (IVI) of slow-release dexamethasone (DEX) are generally well tolerated. Ocular hypertension (OHT) and cataracts are the most common adverse effects of DEX-implant (DEX-I).

Medical and Biotech [MESH] Definitions

The administration of substances into the VITREOUS BODY of the eye with a hypodermic syringe.

The purified component of HEMATOPORPHYRIN DERIVATIVE, it consists of a mixture of oligomeric porphyrins. It is used in photodynamic therapy (HEMATOPORPHYRIN PHOTORADIATION); to treat malignant lesions with visible light and experimentally as an antiviral agent. It is the first drug to be approved in the use of PHOTODYNAMIC THERAPY in the United States.

Treatment of the skin with flashlamps of prescribed wavelengths, fluence, and pulse durations which target specific chromophores to induce photothermolysis at specific locations in the skin such as at the HAIR FOLLICLE or SPIDER VEINS.

A complex mixture of monomeric and aggregated porphyrins used in the photodynamic therapy of tumors (HEMATOPORPHYRIN PHOTORADIATION). A purified component of this mixture is known as DIHEMATOPORPHYRIN ETHER.

An anti-inflammatory 9-fluoro-glucocorticoid.

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