Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01411696
• Collaborator: (none)
• Enrollment: 289
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 36.1

Study Details

Study Description

Brief Summary

This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion; Macular Edema	Drug: dexamethasone intravitreal implant 0.7 mg

Study Design

• Study Type: Observational
• Actual Enrollment: 289 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
All Participants Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.	Drug: dexamethasone intravitreal implant 0.7 mg; Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.; Other Names: OZURDEX®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection [Baseline, 4 to 20 weeks after last injection (Up to 6 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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.

Secondary Outcome Measures

1. Percentage of Participants With an Increase of 2 Lines or More in BCVA [Baseline, Up to 6 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). An increase of 2 or more lines read correctly compared to baseline is an improvement.

2. Percentage of Participants With an Increase of 3 Lines or More in BCVA [Baseline, Up to 6 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). An increase of 3 or more lines read correctly compared to baseline is an improvement.

3. Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection [Baseline, 4 to 20 Weeks after Each injection (up to 6 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 after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Macular edema

• Received at least 2 OZURDEX® injections

Exclusion Criteria:

• Received OZURDEX® injections as part of a clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Antonio	Texas	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01411696
• Other Study ID Numbers: GMA-OZU-09-011; GMA-320
• First Posted: Aug 8, 2011
• Last Update Posted: Apr 16, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Period Title: Overall Study
STARTED	289
COMPLETED	289
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Overall Participants	289
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	71.9 (10.95)
Sex: Female, Male (Count of Participants)
Female	166 57.4%
Male	123 42.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
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 change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.
Time Frame	Baseline, 4 to 20 weeks after last injection (Up to 6 months)

Outcome Measure Data

Analysis Population Description

All participants with data available for analysis.

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Measure Participants	283
Baseline	9.8 (4.62)
Change from baseline at Week 4 to 20 (n=209)	1.0 (3.51)

2. Secondary Outcome

Title	Percentage of Participants With an Increase of 2 Lines or More in 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). An increase of 2 or more lines read correctly compared to baseline is an improvement.
Time Frame	Baseline, Up to 6 months

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Measure Participants	289
Number [Percentage of participants]	62.9 21.8%

3. Secondary Outcome

Title	Percentage of Participants With an Increase of 3 Lines or More in 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). An increase of 3 or more lines read correctly compared to baseline is an improvement.
Time Frame	Baseline, Up to 6 months

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Measure Participants	289
Number [Percentage of participants]	48.1 16.6%

4. Secondary Outcome

Title	Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection
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 after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.
Time Frame	Baseline, 4 to 20 Weeks after Each injection (up to 6 months)

Outcome Measure Data

Analysis Population Description

All participants with data available for analysis.

Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
Measure Participants	247
Baseline	437.8 (181.7)
Change from baseline; first injection (n=242)	-170.8 (179.27)
Change from baseline; second injection (n=232)	-177.6 (185.21)
Change from baseline; third injection (n=128)	-160.9 (172.98)
Change from baseline; fourth injection (n=67)	-155.5 (171.25)
Change from baseline; fifth injection (n=31)	-145.9 (171.27)
Change from baseline; sixth injection (n=16)	-193.4 (186.01)
Change from baseline; seventh injection (n=5)	-220.8 (241.88)
Change from baseline; eighth injection (n=1)	-75.0 (NA)
Change from baseline; ninth injection (n=1)	-61.0 (NA)

Adverse Events

Adverse Event Reporting Description	SAEs (serious adverse events) and AEs (adverse events) were collected retrospectively from chart data.
Arm/Group Title	All Participants
Arm/Group Description	Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	7/289 (2.4%)
Cardiac disorders
Arrhythmia	1/289 (0.3%)
Atrial fibrillation	1/289 (0.3%)
Infections and infestations
Pneumonia	1/289 (0.3%)
Investigations
Heart rate irregular	1/289 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm	1/289 (0.3%)
Lung neoplasm malignant	1/289 (0.3%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/289 (0.3%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	49/289 (17%)
Eye disorders
Cataract	26/289 (9%)
Investigations
Intraocular pressure increased	23/289 (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.