Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Summary
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 cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and associated CME in many patients. However, in many cases, CME persists in spite of adequate suppression of uveitis. No consensus exists on how best to treat such cases. The further addition of immunosuppressive agents appears to have little effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged use can be associated with serious side-effects. Periocular and intravitreal corticosteroid injections are associated with well-known, significant side effects such as glaucoma and cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin IL-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it has been demonstrated that aqueous VEGF concentrations are statistically significantly higher in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our current knowledge of the pathophysiology of this condition and also because of the clinical need for additional treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis.
Study Design
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Uveitic Cystoid Macular Edema
Intervention
ranibizumab
Location
Bascom Palmer Eye Insitute
Miami
Florida
United States
33136
Status
Recruiting
Source
University of Miami
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00826618
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Macular Edema
Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90)
Geographic Atrophy
A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.
Vitreoretinal Surgery
Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.
Edema Disease Of Swine
An acute disease of young pigs that is usually associated with weaning. It is characterized clinically by paresis and subcutaneous edema.
Clinical Trials
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Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema
To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
PubMed Articles
Purpose: To describe the bioactivity of an intercellular adhesion molecule inhibitor (efalizumab) in a patient with refractory uveitic macular edema. Methods: A 55-year-old man presented with idiopath...
PHARMACOLOGIC THERAPY OF PSEUDOPHAKIC CYSTOID MACULAR EDEMA: 2010 Update.
: To review the current management and pharmacologic treatment of pseudophakic cystoid macular edema.
PURPOSE:: To demonstrate the effect of bevacizumab compared with triamcinolone acetonide for the treatment of persistent cystoid macular edema in noninfectious uveitis. METHODS:: The medical records o...
Background: The aim was to evaluate the correlation between the anatomical and functional outcomes before and after treatment of uveitic macular oedema. Methods: Thirty-three eyes of 33 patients...
Cystoid macular edema induced by nab-paclitaxel.
Cystoid macular edema (CME) is a rare complication of taxane-based chemotherapy. We encountered a patient who developed CME during treatment with nab-paclitaxel for metastatic breast cancer. Early det...
