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A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

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ClinicalTrials.gov Identifier: NCT01805323
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : May 30, 2014
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.

Condition or disease Intervention/treatment
Macular Edema Drug: Dexamethasone Intravitreal Implant

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : April 15, 2013
Actual Study Completion Date : April 15, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Groups and Cohorts
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Group/Cohort Intervention/treatment
All Participants
Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
 Drug: Dexamethasone Intravitreal Implant
Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.
Other Name: OZURDEX®


Outcome Measures
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Primary Outcome Measures :
  1. Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) ]
    BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.


Secondary Outcome Measures :
  1. Peak Mean Change From Baseline in Central Retinal Thickness (CRT) [ Time Frame: Baseline, 2 to 26 weeks following last injection (up to 6.5 months) ]
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with macular edema
Criteria

Inclusion Criteria:

  • Retinal disease involving macular edema
  • Received at least one OZURDEX® injection

Exclusion Criteria:

  • None
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): NCT01805323


Locations
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Canada, Quebec
Quebec City, Quebec, Canada
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: NCT01805323    
Other Study ID Numbers: CMA-OZU-12-001
First Posted: March 6, 2013    Key Record Dates
Results First Posted: May 30, 2014
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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