Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

Tuberculosis Clinical Trial

— AVA-ION  

Official title:

Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645697
• Other study ID #: 1955AM
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2008
• Last updated: March 25, 2008
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Rafic Hariri University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Choroiditis
• Harada Toxoplasmosis
• Multifocal Serpiginous Choroiditis
• Neovascularization
• Neovascularization, Pathologic
• Toxoplasmosis
• Tuberculosis

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (4)

Lead Sponsor	Collaborator
Rafic Hariri University Hospital	Heidelberg University, University Hospital Freiburg, University Hospital Tuebingen

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity gain after bevacizumab therapy.		3 month, 1 year, 2 year	Yes
Secondary	fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography.		3 month	No