Uveitis
Conditions
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
Interventions
DRUGbevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
DRUGtriamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular Thickness Measurements Using Stratus Optical Coherence Tomography | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| visual acuity | 48 weeks |
| intraocular pressure | 48 weeks |
| opacity crystalline | 48 weeks |
Countries
Spain
Outcome results
None listed