Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

Completed

• Conditions: Multifocal Serpiginous Choroiditis; Harada Toxoplasmosis; Tuberculosis; Neovascularization

• Registration Number: NCT00645697
• Lead Sponsor: Rafic Hariri University Hospital

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 Description

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.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Last Update Submitted: 2008-03-25
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Inflammatory ocular neovascularization (INO)

Exclusion Criteria

• Eyes with age-related macular degeneration
• Diabetes mellitus
• Prior cystoid macular edema
• Uncontrolled systemic hypertension
• Cardiovascular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity gain after bevacizumab therapy.	3 month, 1 year, 2 year

Secondary Outcome Measures

Name	Time	Method
fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography.	3 month

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon