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
  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

Resource links provided by NLM:


Further study details as provided by Rafic Hariri University Hospital:

Primary Outcome Measures:
  • Best corrected visual acuity gain after bevacizumab therapy. [ Time Frame: 3 month, 1 year, 2 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645697

Locations
Lebanon
American University of Beirut
Beirut, Lebanon, 1136044
Sponsors and Collaborators
Rafic Hariri University Hospital
Heidelberg University
University Hospital Tuebingen
University Hospital Freiburg
Investigators
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 April 17, 2014