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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01095809
Other study ID # EBEV
Secondary ID
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


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
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