A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
Overview
- Phase
- Not Applicable
- Intervention
- Dexamethasone Intravitreal Implant
- Conditions
- Macular Edema
- Sponsor
- Allergan
- Enrollment
- 101
- Primary Endpoint
- Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Retinal disease involving macular edema
- •Received at least one OZURDEX® injection
Exclusion Criteria
- Not provided
Arms & Interventions
All Participants
Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Intervention: Dexamethasone Intravitreal Implant
Outcomes
Primary Outcomes
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 Outcomes
- Peak Mean Change From Baseline in Central Retinal Thickness (CRT)(Baseline, 2 to 26 weeks following last injection (up to 6.5 months))