Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocu... | NCT00645697

Studies
Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

NCT00645697

Sponsor

Rafic Hariri University Hospital

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Neovascularization
Tuberculosis
Multifocal Serpiginous Choroiditis
Harada Toxoplasmosis

Interventions

Not provided

Countries

Lebanon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2008

Last Update Posted Date

Mar 28, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Rafic Hariri University HospitalOTHER

Collaborators

Name	Class
Heidelberg University	OTHER
University Hospital Tuebingen	OTHER
University Hospital Freiburg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity gain after bevacizumab therapy.		3 month, 1 year, 2 year

Secondary Outcomes

Measure	Description	Time Frame
fluorescein leakage of ocular neovascularization by fluorescein angiography and macular thickness by Optical Computed tomography.		3 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad M Mansour, MD	American University of Beirut Rafic Hariri University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American University of Beirut		Beirut		1136044	Lebanon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22687305	Derived	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.
19427992

ID	Term
D009389	Neovascularization, Pathologic
D014376	Tuberculosis
D006660	Histoplasmosis

ID	Term
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009164	Mycobacterium Infections