A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
1 other identifier
observational
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2013
CompletedResults Posted
Study results publicly available
May 30, 2014
CompletedApril 17, 2019
April 1, 2019
8 months
March 5, 2013
April 28, 2014
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
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.
Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)
Secondary Outcomes (1)
Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
Baseline, 2 to 26 weeks following last injection (up to 6.5 months)
Study Arms (1)
All Participants
Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Interventions
Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.
Eligibility Criteria
Patients with macular edema
You may qualify if:
- Retinal disease involving macular edema
- Received at least one OZURDEX® injection
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Québec, Quebec, Canada
Related Publications (1)
Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015.
PMID: 26203215BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 6, 2013
Study Start
September 1, 2012
Primary Completion
April 15, 2013
Study Completion
April 15, 2013
Last Updated
April 17, 2019
Results First Posted
May 30, 2014
Record last verified: 2019-04