A Long-Term Safety Study of OZURDEX® in Clinical Practice
This study is currently recruiting participants.
Verified March 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01539577
First received: February 22, 2012
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Retinal Vein Occlusion Macular Edema Uveitis, Posterior |
Drug: dexamethasone 700 μg intravitreal implant |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
U.S. FDA Resources
Further study details as provided by Allergan:
Primary Outcome Measures:
- Incidence of Patients Reporting Serious Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 650 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
OZURDEX®
OZURDEX® (dexamethasone 700 μg intravitreal implant) administered according to general clinical practice.
|
Drug: dexamethasone 700 μg intravitreal implant
dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
Other Name: OZURDEX®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with macular oedema due to CRVO or BRVO or non-infectious uveitis
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539577
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| France | |
| Recruiting | |
| Paris, France | |
| Germany | |
| Recruiting | |
| Ulm, Germany | |
| Spain | |
| Not yet recruiting | |
| Barcelona, Spain | |
| United Kingdom | |
| Recruiting | |
| Bradford, West Yorks, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
Additional Information:
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01539577 History of Changes |
| Other Study ID Numbers: | 206207-025 |
| Study First Received: | February 22, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Edema Macular Edema Retinal Vein Occlusion Uveitis Chorioretinitis Uveitis, Posterior Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Uveal Diseases Retinitis Choroiditis Choroid Diseases Panuveitis Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
ClinicalTrials.gov processed this record on May 21, 2013