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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01539577
First received: February 22, 2012
Last updated: April 18, 2016
Last verified: April 2016
  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: 875
Study Start Date: March 2012
Study Completion Date: March 2016
Primary Completion Date: March 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   (Adult, Senior)
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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01539577     History of Changes
Other Study ID Numbers: 206207-025 
Study First Received: February 22, 2012
Last Updated: April 18, 2016
Health Authority: European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on July 28, 2016