Clinical Trial: Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study

Brief Summary: One complication of uveitis which is driven by an increase in VEGF is the formation of inflammatory ocular neovascularization (ION). Here, we analyze the therapeutic role of intravitreal bevacizumab in ION not responding to standard therapy (systemic and ocular corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.The natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis, Harada and other inflammatory chorioretinal disorders has been very guarded, but with this new approach, we hope to stop the visual loss in these relatively young patients.

Detailed Summary: Members of the American Society of Retinal specialists, the American Uveitis Society and the International Uveitis Society were invited to contribute their consecutive cases of ION not responding to standard therapy (corticosteroids (CST) 4 or immunosuppression) and treated with intravitreal anti-VEGF agents. Cases with concomitant or prior cystoid macular edema, diabetes mellitus, or age-related macular degeneration were excluded. Most of the patients had initially been treated in a stepwise fashion with high doses of oral CST, with or without intraocular or subtenon CST or immunosuppressive therapy (as monitored by a rheumatologist). All patients opted to intravitreal anti-VEGF treatment after detailed information about the limited experience, potential side effects and the off-label character of the drug. The risks and benefits of intravitreal therapy were discussed with the patients (or their guardians) who signed an informed consent. Primary outcome measure: Best corrected visual acuity measured as logMAR. Secondary outcome measures:macular thickness on OCT, and stoppage of leakage by IVFA.
Sponsor: Rafic Hariri University Hospital

Current Primary Outcome: Best corrected visual acuity gain after bevacizumab therapy. [ Time Frame: 3 month, 1 year, 2 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography. [ Time Frame: 3 month ]

Original Secondary Outcome: Same as current

Information By: Rafic Hariri University Hospital

Dates:
Date Received: March 25, 2008
Date Started: January 2007
Date Completion:
Last Updated: March 25, 2008
Last Verified: March 2008