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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01539577
Other study ID # 206207-025
Secondary ID
Status Completed
Phase N/A
First received February 22, 2012
Last updated April 18, 2016
Start date March 2012
Est. completion date March 2016

Study information

Verified date April 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 875
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Macular oedema following either BRVO or CRVO or non-infectious uveitis

- Requires treatment with OZURDEX®

Exclusion Criteria:

- Current participation in any clinical study

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
dexamethasone 700 µg intravitreal implant
dexamethasone 700 µg intravitreal implant administered according to general clinical practice.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

France,  Germany,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Patients Reporting Serious Adverse Events 2 years No
Primary 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. 2 years No
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