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Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema (EBEV)

Primary Purpose

Uveitis

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
bevacizumab
triamcinolone acetonide
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Son Dureta
  • Hospital Santa creu i Sant Pau
  • Instituto Vissum Alicante
  • Hospital Vall d'Hebron
  • Hospital Clinic of Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bevacizumab

triamcinolone acetonide

Arm Description

intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.

intravitreous triamcinolone 2 mg, frequency: 3 months

Outcomes

Primary Outcome Measures

Macular Thickness Measurements Using Stratus Optical Coherence Tomography

Secondary Outcome Measures

visual acuity
intraocular pressure
opacity crystalline

Full Information

First Posted
March 29, 2010
Last Updated
March 22, 2012
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01095809
Brief Title
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema
Acronym
EBEV
Official Title
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Terminated
Why Stopped
New intraocular steroid in the market. Recruitment no longer ethical.
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Experimental
Arm Description
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
Arm Title
triamcinolone acetonide
Arm Type
Experimental
Arm Description
intravitreous triamcinolone 2 mg, frequency: 3 months
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
Primary Outcome Measure Information:
Title
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
visual acuity
Time Frame
48 weeks
Title
intraocular pressure
Time Frame
48 weeks
Title
opacity crystalline
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital de Son Dureta
City
palma de Mallorca
State/Province
Spain/ Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Santa creu i Sant Pau
City
Barcelona
State/Province
Spain/ catalonia
ZIP/Postal Code
08025
Country
Spain
Facility Name
Instituto Vissum Alicante
City
Alicante
State/Province
Spain/ Com. Valenciana
ZIP/Postal Code
03016
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
State/Province
Spain/Catalonia
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
State/Province
Spain/Catalonia
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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