Lucentis for Inflammatory Macular Edema Trial

2014-08-26 22:37:30 | BioPortfolio

Summary

Uveitis is an inflammation (swelling and irritation) inside the eye, affecting the uvea. The uvea is the layer of the eye between the sclera and the retina and provides most of the blood supply to the retina.

Uveitis is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammation is controlled. The only current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional steroid injections. For patients who don't respond to steroids or who are unable to tolerate steroid therapy, there are no other medical treatments.

The aim of this study is to determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or non-responsive to steroids.

Description

Uveitis, an inflammation that affects the uvea (iris, ciliary body and choroid), is an important cause of visual loss. There are 30,000 new cases of legal blindness each year due to uveitis in the U.S. Sight-threatening complications associated with uveitis include macular edema, which may persist even when inflammation is controlled. The only current treatment for cystoid macular edema (CME) in uveitis patients is oral or regional steroid injections. For patients who don't respond to steroids or who are unable to tolerate steroid therapy, there are no other medical treatments.

The aim of the proposed research is to determine if ranibizumab is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or non-responsive to steroids. Ranibizumab is a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of vascular endothelial growth factor (VEGF). VEGF is suspected to play a role in the loss of vascular integrity in the eye, which is thought to be involved in the pathogenesis of macular edema in the eyes of patients with uveitis. Ranibizumab was approved by the FDA for the treatment of neovascular age-related macular degeneration on June 30, 2006, and a number of published papers have shown efficacy for other causes of macular edema, including that due to diabetes mellitus.

The F. I. Proctor Foundation at UCSF will be enrolling 10 subjects 18 years of age or older with uveitis-induced CME to clinically evaluate the safety and effectiveness of ranibizumab administered monthly for three months followed by PRN monthly dosing (up to 12 months). The study will measure visual acuity, changes in foveal thickness on optical coherence tomography, and changes in cystoid macular edema by fluorescein angiograpy to determine the efficacy of ranibizumab treatment.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uveitis

Intervention

Lucentis (ranibizumab)

Location

Proctor Foundation, UCSF
San Francisco
California
United States
94143

Status

Recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:37:30-0400

Clinical Trials [235 Associated Clinical Trials listed on BioPortfolio]

Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema

Uveitic CME is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as cyclosp...

Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids

This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to c...

A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD

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Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneratio...

Efficacy and Safety of Lucentis® (Ranibizumab Intravitreal Injections) in Chilean Patients With Diabetic Macular Edema.

Lucentis® (ranibizumab) is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment o...

PubMed Articles [152 Associated PubMed Articles listed on BioPortfolio]

A model of the ocular pharmacokinetics involved in the therapy of neovascular age-related macular degeneration with ranibizumab.

To develop a model of the pharmacokinetics of vascular endothelial growth factor (VEGF-A) determined in samples of aqueous humour from patients with neovascular age-related macular degeneration (AMD) ...

Association of Systemic Lupus Erythematosus With Uveitis.

Systemic lupus erythematosus (SLE) can be associated with uveitis. The reported prevalence of SLE in patients with uveitis varies from 0.1% to 4.8%. Accordingly, the positive predictive value of antin...

Pathogenesis of innate immunity and adaptive immunity in the mouse model of experimental autoimmune uveitis.

Experimental autoimmune uveitis, a well-established model for human uveitis, is similar to human uveitis in many pathological features. Studies concerning the mechanisms of experimental autoimmune uve...

RETROSPECTIVE REVIEW OF LUCENTIS "TREAT AND EXTEND" PATTERNS AND OUTCOMES IN AGE-RELATED MACULAR DEGENERATION.

To assess patterns and outcomes of a "Treat and Extend" dosing regimen of ranibizumab in patients with age-related macular degeneration.

Uveitis events upon Adalimumab, Etanercept and methotrexate in juvenile idiopathic arthritis (JIA) in the BIKER-registry.

Uveitis is a major extraarticular quality of life restriciting manifestation of JIA. The aim of the study is to describe the occurrence of uveitis in JIA patients receiving TNF-inhibitors or methotrex...

Medical and Biotech [MESH] Definitions

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Inflammation of the pars plana, ciliary body, and adjacent structures.

Abnormally low intraocular pressure often related to chronic inflammation (uveitis).

Inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (sclera and cornea, and the retina). (Dorland, 27th ed)

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