Study Stopped
New intraocular steroid in the market. Recruitment no longer ethical.
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema
EBEV
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
1 other identifier
interventional
5
1 country
5
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
Typical duration for phase_3
5 active sites
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
First Submitted
Initial submission to the registry
March 29, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMarch 23, 2012
December 1, 2010
3 years
March 29, 2010
March 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
48 weeks
Secondary Outcomes (3)
visual acuity
48 weeks
intraocular pressure
48 weeks
opacity crystalline
48 weeks
Study Arms (2)
bevacizumab
EXPERIMENTALintravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
triamcinolone acetonide
EXPERIMENTALintravitreous triamcinolone 2 mg, frequency: 3 months
Interventions
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hospital de Son Dureta
Palma de Mallorca, Spain/ Baleares, 07014, Spain
Hospital Santa creu i Sant Pau
Barcelona, Spain/ Catalonia, 08025, Spain
Instituto Vissum Alicante
Alicante, Spain/ Com. Valenciana, 03016, Spain
Hospital Vall d'Hebron
Barcelona, Spain/Catalonia, 08035, Spain
Hospital Clinic of Barcelona
Barcelona, Spain/Catalonia, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 29, 2010
First Posted
March 30, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 23, 2012
Record last verified: 2010-12