Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization (AVA-ION)
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Purpose
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 | Phase |
|---|---|
|
Neovascularization Tuberculosis Multifocal Serpiginous Choroiditis Harada Toxoplasmosis |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization: Multicenter Collaborative Study |
- Best corrected visual acuity gain after bevacizumab therapy. [ Time Frame: 3 month, 1 year, 2 year ] [ Designated as safety issue: Yes ]
- fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
| Enrollment: | 100 |
| Study Start Date: | January 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Lebanon | |
| American University of Beirut | |
| Beirut, Lebanon, 1136044 | |
| Principal Investigator: | Ahmad M Mansour, MD | American University of Beirut Rafic Hariri University Hospital |
More Information
No publications provided by Rafic Hariri University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ahmad Mansour, AUB |
| ClinicalTrials.gov Identifier: | NCT00645697 History of Changes |
| Other Study ID Numbers: | 1955AM |
| Study First Received: | March 25, 2008 |
| Last Updated: | March 25, 2008 |
| Health Authority: | Lebanon: Institutional Review Board |
Keywords provided by Rafic Hariri University Hospital:
|
tuberculosis Multifocal serpiginous choroiditis histoplasmosis Harada toxoplasmosis |
Additional relevant MeSH terms:
|
Choroiditis Neovascularization, Pathologic Toxoplasmosis Tuberculosis Choroid Diseases Uveal Diseases Eye Diseases Uveitis, Posterior Panuveitis Uveitis Metaplasia Pathologic Processes Coccidiosis Protozoan Infections |
Parasitic Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013