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A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01571557
First received: April 3, 2012
Last updated: July 7, 2014
Last verified: July 2014

April 3, 2012
July 7, 2014
April 2012
March 2014   (final data collection date for primary outcome measure)
Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01571557 on ClinicalTrials.gov Archive Site
Change from Baseline in Central Retinal Thickness [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
Not Provided

This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with macular oedema due to retinal vein occlusion

  • Macular Edema
  • Retinal Vein Occlusion
Drug: dexamethasone 700 ug intravitreal implant
dexamethasone 700 ug intravitreal implant administered according to standard of care.
Other Name: OZURDEX®
OZURDEX®
OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Intervention: Drug: dexamethasone 700 ug intravitreal implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
622
June 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of macular edema following retinal vein occlusion
  • Prescribed OZURDEX®

Exclusion Criteria:

  • Previous treatment with OZURDEX®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01571557
MAF/AGN/OPH/RET/011
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP