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

Uveitis Clinical Trial

— EBEV  

Official title:

Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01095809
• Other study ID #: EBEV
• Status: Terminated
• Phase: Phase 3
• First received: March 29, 2010
• Last updated: March 22, 2012
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2010
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Uveitis

Intervention

Drug:
• bevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
• triamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol

Locations

Country	Name	City	State
Spain	Instituto Vissum Alicante	Alicante	Spain/ Com. Valenciana
Spain	Hospital Clinic of Barcelona	Barcelona	Spain/Catalonia
Spain	Hospital Santa creu i Sant Pau	Barcelona	Spain/ catalonia
Spain	Hospital Vall d'Hebron	Barcelona	Spain/Catalonia
Spain	Hospital de Son Dureta	palma de Mallorca	Spain/ Baleares

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular Thickness Measurements Using Stratus Optical Coherence Tomography		48 weeks	No
Secondary	visual acuity		48 weeks	No
Secondary	intraocular pressure		48 weeks	No
Secondary	opacity crystalline		48 weeks	No