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

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805323
• Other study ID #: CMA-OZU-12-001
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: April 15, 2013

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 15, 2013
• Est. primary completion date: April 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Retinal disease involving macular edema

• Received at least one OZURDEX® injection

Exclusion Criteria:

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone Intravitreal Implant
Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak Mean Change From Baseline in Central Retinal Thickness (CRT)	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.	Baseline, 2 to 26 weeks following last injection (up to 6.5 months)