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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01805323
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Actual Duration (Months): 7.4
• Patients Per Site Per Month: 13.6

Study Details

Study Description

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	Phase
Macular Edema	Drug: Dexamethasone Intravitreal Implant

Study Design

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

Arms and Interventions

Arm	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 Names: OZURDEX®

Outcome Measures

Primary Outcome Measures

1. Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) [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) [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Retinal disease involving macular edema

• Received at least one OZURDEX® injection

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Quebec City	Quebec	Canada

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01805323
• Other Study ID Numbers: CMA-OZU-12-001
• First Posted: Mar 6, 2013
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Macular Edema; Edema; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Period Title: Overall Study
STARTED	101
COMPLETED	101
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Overall Participants	101
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	60.9 (14.8)
Sex: Female, Male (Count of Participants)
Female	35 34.7%
Male	66 65.3%

Outcome Measures

1. Primary Outcome

Title	Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
Description	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.
Time Frame	Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)

Outcome Measure Data

Analysis Population Description

All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.

Arm/Group Title	All Participants
Arm/Group Description	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Measure Participants	78
Measure Eyes	90
Baseline	6.3 (0.3)
Change from Baseline 2-26 wks after last injection	1.4 (0.3)

2. Secondary Outcome

Title	Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
Description	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.
Time Frame	Baseline, 2 to 26 weeks following last injection (up to 6.5 months)

Outcome Measure Data

Analysis Population Description

All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.

Arm/Group Title	All Participants
Arm/Group Description	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
Measure Participants	75
Measure Eyes	85
Baseline	474.4 (18.2)
Change from Baseline 2-26 wks after last injection	-183.4 (17.9)

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	4/101 (4%)
Eye disorders
Endophthalmitis	1/101 (1%)
Uveitis	1/101 (1%)
Injury, poisoning and procedural complications
Retinal detachment	1/101 (1%)
Surgical and medical procedures
Retinal implant	1/101 (1%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	25/101 (24.8%)
Eye disorders
Cystoid macular oedema	6/101 (5.9%)
Investigations
Intraocular pressure increased	19/101 (18.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.