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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01539577
First received: February 22, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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:


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.


Enrollment: 880
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539577

Locations
France
Paris, France
Germany
Ulm, Germany
Spain
Barcelona, Spain
United Kingdom
Bradford, West Yorks, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More 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 24, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Uveitis, Posterior
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Panuveitis
Retinal Degeneration
Retinal Diseases
Thrombosis
Uveal Diseases
Uveitis
Vascular Diseases
Venous Thrombosis
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 25, 2014