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

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ClinicalTrials.gov Identifier: NCT00645697
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Collaborators:
Heidelberg University
University Hospital Tuebingen
University Hospital Freiburg
Information provided by:
Rafic Hariri University Hospital

Tracking Information
First Submitted Date March 25, 2008
First Posted Date March 28, 2008
Last Update Posted Date March 28, 2008
Study Start Date January 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2008)
Best corrected visual acuity gain after bevacizumab therapy. [ Time Frame: 3 month, 1 year, 2 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 25, 2008)
fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography. [ Time Frame: 3 month ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Retrospective review of INO treated by the 25 collaborators from the 5 continents.
Condition
  • Neovascularization
  • Tuberculosis
  • Multifocal Serpiginous Choroiditis
  • Harada Toxoplasmosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 25, 2008)
100
Original Actual Enrollment Same as current
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number NCT00645697
Other Study ID Numbers 1955AM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ahmad Mansour, AUB
Study Sponsor Rafic Hariri University Hospital
Collaborators
  • Heidelberg University
  • University Hospital Tuebingen
  • University Hospital Freiburg
Investigators
Principal Investigator: Ahmad M Mansour, MD American University of Beirut Rafic Hariri University Hospital
PRS Account Rafic Hariri University Hospital
Verification Date March 2008