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

Phase 3

Terminated

• Conditions: Uveitis
• Interventions: Drug: triamcinolone acetonide; Drug: bevacizumab

• Registration Number: NCT01095809
• Lead Sponsor: Hospital Clinic of Barcelona

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 available

Study Timeline

• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2010-04
• Status Verified: 2010-12
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-23
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Macular Thickness Measurements Using Stratus Optical Coherence Tomography	48 weeks

Secondary Outcome Measures

Name	Time	Method
visual acuity	48 weeks
intraocular pressure	48 weeks
opacity crystalline	48 weeks

Trial Locations

Locations (5)

Hospital de Son Dureta; 🇪🇸 palma de Mallorca, Spain/ Baleares, Spain

Hospital Santa creu i Sant Pau; 🇪🇸 Barcelona, Spain/ catalonia, Spain

Instituto Vissum Alicante; 🇪🇸 Alicante, Spain/ Com. Valenciana, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain/Catalonia, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain/Catalonia, Spain