Efficacy, Safety and Tolerability of Repeated Dosis of In... | NCT01095809

Studies
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema

NCT01095809

Sponsor

Hospital Clinic of Barcelona

Status

Terminated

Last Update Posted

Mar 23, 2012Estimated

Enrollment

5Actual

Phase

Phase 3

Conditions

Uveitis

Interventions

bevacizumab
triamcinolone acetonide

Countries

Spain

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

Dec 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

New intraocular steroid in the market. Recruitment no longer ethical.

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

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 22, 2012

Last Update Posted Date

Mar 23, 2012Estimated

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

The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bevacizumab	Experimental	intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.	Drug: bevacizumab
triamcinolone acetonide	Experimental	intravitreous triamcinolone 2 mg, frequency: 3 months	Drug: triamcinolone acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol	bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular Thickness Measurements Using Stratus Optical Coherence Tomography		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
visual acuity		48 weeks
intraocular pressure		48 weeks
opacity crystalline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
with macular thickness > 250 micra using OCT
visual acuity at least 20/200
with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
patient that can follow study's requirements
patient who consents to participate

Exclusion Criteria:

presence of corneal or crystalline opacity preventing observation of fundus of eye
patients requiring ocular surgery in next 3 months
one-eyed
pregnancy and child breastfeeding
previous history of glaucoma
on treatment woth an experimental ocular drug
previous thromboembolism or receiving oral anticoagulant treatment
vitrectomy
patients with proved tractional macular pathology associated to macular oedema

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Son Dureta		Palma de Mallorca	Spain/ Baleares	07014	Spain
Hospital Santa creu i Sant Pau

ID	Term
D014605	Uveitis

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided