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CompletedNCT01539577Updated Apr 20, 2016

A Long-Term Safety Study of OZURDEX® in Clinical Practice

An observational study in Retinal Vein Occlusion, Macular Edema and Uveitis, Posterior, sponsored by Allergan. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Allergan (part of AbbVie) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
875
Ages
18 Years and older
Sex
All
01

Study summary

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

02

Conditions studied

  • Retinal Vein Occlusion
  • Macular Edema
  • Uveitis, Posterior
03

In context

Retinal Vein Occlusion

289 studies on the registry are indexed under Retinal Vein Occlusion; 32 are open to participants now.

This study's enrollment of 875 is above the median of 165 across 70 observational studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with macular oedema due to CRVO or BRVO or non-infectious uveitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Macular oedema following either BRVO or CRVO or non-infectious uveitis
  • Requires treatment with OZURDEX®

Exclusion criteria

Exclusion Criteria:

  • Current participation in any clinical study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
875 participants (actual)

Groups and cohorts

  • OZURDEX®

    OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.

    Drug: dexamethasone 700 μg intravitreal implant

Interventions

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What researchers measure

Primary outcomes

  1. Incidence of Patients Reporting Serious Adverse Events

    Time frame: 2 years

  2. Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest

    The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement.

    Time frame: 2 years

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Study locations

4 sites
  • Paris, France
  • Ulm, Germany
  • Barcelona, Spain
  • Bradford, West Yorks, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01539577
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Mar 2012
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Apr 20, 2016

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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