Macular Edema, Retinal Vein Occlusion, Uveitis, Posterior
Conditions
Brief 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.
Interventions
DRUGdexamethasone 700 μg intravitreal implant
dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Patients Reporting Serious Adverse Events | 2 years | — |
| Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest | 2 years | 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. |
Countries
France, Germany, Spain, United Kingdom
Outcome results
None listed