NCT00645697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

March 25, 2008

Last Update Submit

March 25, 2008

Conditions

NeovascularizationTuberculosisMultifocal Serpiginous ChoroiditisHarada Toxoplasmosis

Keywords

tuberculosisMultifocal serpiginous choroiditishistoplasmosisHarada toxoplasmosis

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity gain after bevacizumab therapy.

    3 month, 1 year, 2 year

Secondary Outcomes (1)

  • fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography.

    3 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Inflammatory ocular neovascularization (INO)

You may not qualify if:

  • Eyes with age-related macular degeneration
  • Diabetes mellitus
  • Prior cystoid macular edema
  • Uncontrolled systemic hypertension
  • Cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 1136044, Lebanon

Location

Related Publications (3)

  • Mansour AM, Arevalo JF, Fardeau C, Hrisomalos EN, Chan WM, Lai TY, Ziemssen F, Ness T, Sibai AM, Mackensen F, Wolf A, Hrisomalos N, Heiligenhaus A, Spital G, Jo Y, Gomi F, Ikuno Y, Akesbi J, LeHoang P, Adan A, Mahendradas P, Khairallah M, Guthoff R, Ghandour B, Kucukerdonmez C, Kurup SK. Three-year visual and anatomic results of administrating intravitreal bevacizumab in inflammatory ocular neovascularization. Can J Ophthalmol. 2012 Jun;47(3):269-74. doi: 10.1016/j.jcjo.2012.03.042.

    PMID: 22687305DERIVED

  • Mansour AM, Arevalo JF, Ziemssen F, Mehio-Sibai A, Mackensen F, Adan A, Chan WM, Ness T, Banker AS, Dodwell D, Chau Tran TH, Fardeau C, Lehoang P, Mahendradas P, Berrocal M, Tabbarah Z, Hrisomalos N, Hrisomalos F, Al-Salem K, Guthoff R. Long-term visual outcomes of intravitreal bevacizumab in inflammatory ocular neovascularization. Am J Ophthalmol. 2009 Aug;148(2):310-316.e2. doi: 10.1016/j.ajo.2009.03.023. Epub 2009 May 9.

    PMID: 19427992DERIVED

  • Mansour AM, Mackensen F, Arevalo JF, Ziemssen F, Mahendradas P, Mehio-Sibai A, Hrisomalos N, Lai TY, Dodwell D, Chan WM, Ness T, Banker AS, Pai SA, Berrocal MH, Tohme R, Heiligenhaus A, Bashshur ZF, Khairallah M, Salem KM, Hrisomalos FN, Wood MH, Heriot W, Adan A, Kumar A, Lim L, Hall A, Becker M. Intravitreal bevacizumab in inflammatory ocular neovascularization. Am J Ophthalmol. 2008 Sep;146(3):410-416. doi: 10.1016/j.ajo.2008.05.024. Epub 2008 Jul 10.

    PMID: 18619571DERIVED

MeSH Terms

Conditions

Neovascularization, PathologicTuberculosisHistoplasmosis

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMycoses

Study Officials

  • Ahmad M Mansour, MD

    American University of Beirut Rafic Hariri University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

LE(1)