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

This study has been completed.
Sponsor:
Collaborators:
Heidelberg University
University Hospital Tuebingen
University Hospital Freiburg
Information provided by:
Rafic Hariri University Hospital
ClinicalTrials.gov Identifier:
NCT00645697
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 25, 2008
March 25, 2008
January 2007
March 2008   (final data collection date for primary outcome measure)
Best corrected visual acuity gain after bevacizumab therapy. [ Time Frame: 3 month, 1 year, 2 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization
Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Retrospective review of INO treated by the 25 collaborators from the 5 continents.

  • Neovascularization
  • Tuberculosis
  • Multifocal Serpiginous Choroiditis
  • Harada Toxoplasmosis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Lebanon
 
NCT00645697
1955AM
No
Ahmad Mansour, AUB
Rafic Hariri University Hospital
  • Heidelberg University
  • University Hospital Tuebingen
  • University Hospital Freiburg
Principal Investigator: Ahmad M Mansour, MD American University of Beirut Rafic Hariri University Hospital
Rafic Hariri University Hospital
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP