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

H

Hospital Clinic of Barcelona

Status and phase

Terminated
Phase 3

Conditions

Uveitis

Treatments

Drug: bevacizumab
Drug: triamcinolone acetonide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

bevacizumab
Experimental group
Description:
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
Treatment:
Drug: bevacizumab
triamcinolone acetonide
Experimental group
Description:
intravitreous triamcinolone 2 mg, frequency: 3 months
Treatment:
Drug: triamcinolone acetonide

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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