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Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization (AVA-ION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645697
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Heidelberg University
University Hospital Tuebingen
University Hospital Freiburg
Information provided by:
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.

Condition or disease
Neovascularization Tuberculosis Multifocal Serpiginous Choroiditis Harada Toxoplasmosis

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Retrospective review of INO treated by the 25 collaborators from the 5 continents.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645697

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American University of Beirut
Beirut, Lebanon, 1136044
Sponsors and Collaborators
Rafic Hariri University Hospital
Heidelberg University
University Hospital Tuebingen
University Hospital Freiburg
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Principal Investigator: Ahmad M Mansour, MD American University of Beirut Rafic Hariri University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ahmad Mansour, AUB Identifier: NCT00645697    
Other Study ID Numbers: 1955AM
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Keywords provided by Rafic Hariri University Hospital:
Multifocal serpiginous choroiditis
Harada toxoplasmosis
Additional relevant MeSH terms:
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Neovascularization, Pathologic
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pathologic Processes
Protozoan Infections
Parasitic Diseases
Choroid Diseases
Uveal Diseases
Eye Diseases
Uveitis, Posterior