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

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ClinicalTrials.gov Identifier: NCT01571557
Recruitment Status : Completed
First Posted : April 5, 2012
Results First Posted : July 20, 2015
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Macular Edema Retinal Vein Occlusion Drug: dexamethasone 700 ug intravitreal implant

Study Design
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Study Type : Observational
Actual Enrollment : 573 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 30, 2012
Actual Primary Completion Date : March 31, 2014
Actual Study Completion Date : June 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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Group/Cohort Intervention/treatment
OZURDEX®
OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
 Drug: dexamethasone 700 ug intravitreal implant
dexamethasone 700 ug intravitreal implant administered according to standard of care.
Other Name: OZURDEX®


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, Week 12 ]
    BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.


Secondary Outcome Measures :
  1. Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye [ Time Frame: Baseline, 48 Weeks ]
    BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.

  2. Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye [ Time Frame: Baseline, 48 Weeks ]
    BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.

  3. Mean Change From Baseline in Central Retinal Thickness [ Time Frame: Baseline, Week 24 ]
    Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with macular oedema due to retinal vein occlusion
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment with OZURDEX®
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571557


Locations
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Germany
Berlin, Germany
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01571557    
Other Study ID Numbers: MAF/AGN/OPH/RET/011
First Posted: April 5, 2012    Key Record Dates
Results First Posted: July 20, 2015
Last Update Posted: April 19, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Dexamethasone
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