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Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

NCT00645697 — Completed, 100 participants, Rafic Hariri University Hospital

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Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study

RegistryNCT00645697, acronym AVA-ION
StatusCompleted
Study typeObservational
Enrollment100 (Actual)
SponsorRafic Hariri University Hospital (Other); collaborators: Heidelberg University, University Hospital Tuebingen, University Hospital Freiburg
ConditionsNeovascularization, Tuberculosis, Multifocal Serpiginous Choroiditis, Harada Toxoplasmosis
Datesstart 2007-01-01, primary completion 2008-03-01, completion 2008-03-01, first posted 2008-03-28, last updated 2008-03-28
Locations1 site in Lebanon

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-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.

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+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.

+Outcome measures

Primary outcomes

  • Best corrected visual acuity gain after bevacizumab therapy. [3 month, 1 year, 2 year]

Secondary outcomes

  • fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography. [3 month]

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
American University of BeirutBeirutLebanon

+Publications

  • Results publication: Mansour AM, Arevalo JF, Fardeau C, Hrisomalos EN, Chan WM, Lai TY, Ziemssen F, Ness T, Sibai AM, Mackensen F, Wolf A, Hrisomalos N, Heiligenhaus A, Spital G, Jo Y, Gomi F, Ikuno Y, Akesbi J, LeHoang P, Adan A, Mahendradas P, Khairallah M, Guthoff R, Ghandour B, Kucukerdonmez C, Kurup SK. Three-year visual and anatomic results of administrating intravitreal bevacizumab in inflammatory ocular neovascularization. Can J Ophthalmol. 2012 Jun;47(3):269-74. doi: 10.1016/j.jcjo.2012.03.042. PMID 22687305
  • Results publication: Mansour AM, Arevalo JF, Ziemssen F, Mehio-Sibai A, Mackensen F, Adan A, Chan WM, Ness T, Banker AS, Dodwell D, Chau Tran TH, Fardeau C, Lehoang P, Mahendradas P, Berrocal M, Tabbarah Z, Hrisomalos N, Hrisomalos F, Al-Salem K, Guthoff R. Long-term visual outcomes of intravitreal bevacizumab in inflammatory ocular neovascularization. Am J Ophthalmol. 2009 Aug;148(2):310-316.e2. doi: 10.1016/j.ajo.2009.03.023. Epub 2009 May 9. PMID 19427992
  • Results publication: Mansour AM, Mackensen F, Arevalo JF, Ziemssen F, Mahendradas P, Mehio-Sibai A, Hrisomalos N, Lai TY, Dodwell D, Chan WM, Ness T, Banker AS, Pai SA, Berrocal MH, Tohme R, Heiligenhaus A, Bashshur ZF, Khairallah M, Salem KM, Hrisomalos FN, Wood MH, Heriot W, Adan A, Kumar A, Lim L, Hall A, Becker M. Intravitreal bevacizumab in inflammatory ocular neovascularization. Am J Ophthalmol. 2008 Sep;146(3):410-416. doi: 10.1016/j.ajo.2008.05.024. Epub 2008 Jul 10. PMID 18619571

+Investigators

  • Ahmad M Mansour, MD, Principal investigator, American University of Beirut Rafic Hariri University Hospital

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