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

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539577
• Other study ID #: 206207-025
• 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

• Macular Edema
• Retinal Vein Occlusion
• Uveitis, Posterior

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