A Long-Term Safety Study of OZURDEX® in Clinical Practice
Overview
- Phase
- Not Applicable
- Intervention
- dexamethasone 700 μg intravitreal implant
- Conditions
- Retinal Vein Occlusion
- Sponsor
- Allergan
- Enrollment
- 875
- Primary Endpoint
- Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
OZURDEX®
OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.
Intervention: dexamethasone 700 μg intravitreal implant
Outcomes
Primary Outcomes
Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest
Time Frame: 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.
Incidence of Patients Reporting Serious Adverse Events
Time Frame: 2 years