Macular Edema Clinical Trial
Verified date | April 2016 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: European Medicines Agency |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
France, Germany, Spain, United Kingdom,
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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