Study of Ozurdex® Treatment Practice in Patients With Macular Oedema Due to Retinal Vein Occlusion

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01618266
• Collaborator: (none)
• Enrollment: 375
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 375 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Ozurdex® (dexamethasone intravitreal implant) dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.	Drug: dexamethasone intravitreal implant; dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.; Other Names: Ozurdex®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

Secondary Outcome Measures

1. Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.

2. Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.

3. Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.

4. Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.

5. Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.

6. Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.

7. Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.

8. Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.

9. Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments [Baseline, Month 6]

   BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.

10. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [Baseline, Week 6, Month 4, Month 12, Month 18, Month 24]

    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.

11. Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye [Baseline, Month 24]

    BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Macular oedema due to retinal vein occlusion

Exclusion Criteria:

• Not living in metropolitan France

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Paris		France

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: NCT01618266
• Other Study ID Numbers: MAF/AGN/OPH/RET/009
• First Posted: Jun 13, 2012
• Last Update Posted: Mar 14, 2016
• Last Verified: Feb 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Period Title: Overall Study
STARTED	375
COMPLETED	279
NOT COMPLETED	96

Baseline Characteristics

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Overall Participants	375
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	70.31 (11.19)
Sex: Female, Male (Count of Participants)
Female	169 45.1%
Male	206 54.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	375
Baseline	47.56 (21.21)
Change from Baseline at Month 6 (N=323)	5.09 (19.02)

2. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients with BRVO

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	202
Baseline	52.80 (17.42)
Change from Baseline at Month 6	5.50 (19.59)

3. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients with CRVO

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	173
Baseline	41.45 (23.54)
Change from Baseline at Month 6	4.63 (18.38)

4. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients who were treatment naïve

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	145
Baseline	43.94 (23.12)
Change from Baseline at Month 6	7.45 (20.00)

5. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients previously treated with Ozurdex®

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	149
Baseline	52.46 (18.90)
Change from Baseline at Month 6	1.95 (16.03)

6. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients previously naïve to Ozurdex® treatment

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	79
Baseline	45.29 (20.20)
Change from Baseline at Month 6	8.39 (21.10)

7. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients with macular edema onset <3 months

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	180
Baseline	43.27 (22.83)
Change from Baseline at Month 6	8.53 (20.50)

8. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients with macular edema onset ≥3 months

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	183
Baseline	51.44 (19.00)
Change from Baseline at Month 6	1.96 (17.47)

9. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients only treated with Ozurdex

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	254
Baseline	49.28 (19.23)
Change from Baseline at Month 6	5.48 (18.77)

10. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

All enrolled patients receiving Ozurdex® and then other RVO treatments

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	121
Baseline	43.97 (24.57)
Change from Baseline at Month 6	4.25 (19.61)

11. Secondary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.
Time Frame	Baseline, Week 6, Month 4, Month 12, Month 18, Month 24

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	375
Baseline	47.6 (21.2)
Change from Baseline at Week 6 (N=350)	11.41 (16.4)
Change from Baseline at Month 4 (N=337)	3.08 (18.2)
Change from Baseline at Month 12 (N=306)	2.85 (21.4)
Change from Baseline at Month 18 (N=287)	3.02 (22.2)
Change from Baseline at Month 24 (N=274)	4.64 (22.3)

12. Secondary Outcome

Title	Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
Description	BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Time Frame	Baseline, Month 24

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
Measure Participants	375
Number [Percentage of Patients]	38.7

Adverse Events

Arm/Group Title	Ozurdex® (Dexamethasone Intravitreal Implant)
Arm/Group Description	dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
All Cause Mortality
	Ozurdex® (Dexamethasone Intravitreal Implant)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ozurdex® (Dexamethasone Intravitreal Implant)
	Affected / at Risk (%)	# Events
Total	98/375 (26.1%)
Cardiac disorders
Cardiac Arrest	1/375 (0.3%)
Cardiopulmonary Arrest	1/375 (0.3%)
Eye disorders
Ocular Hypertension	32/375 (8.5%)
Cataract	26/375 (6.9%)
Glaucoma	6/375 (1.6%)
Vitreous Haemorrhage	3/375 (0.8%)
Macular Fibrosis	2/375 (0.5%)
Subscapular Cataract	1/375 (0.3%)
Detached Retina	1/375 (0.3%)
Macular Degeneration	1/375 (0.3%)
Retinal Ischaemia	1/375 (0.3%)
Gastrointestinal disorders
Acute Pancreatitis	1/375 (0.3%)
General disorders
Death	2/375 (0.5%)
Infections and infestations
Pulmonary Infection	1/375 (0.3%)
Herpetic Keratitis	1/375 (0.3%)
Metabolism and nutrition disorders
Diabetes	1/375 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma	1/375 (0.3%)
Prostate tumour	1/206 (0.5%)
Nervous system disorders
Stroke	2/375 (0.5%)
Sudden Falls Due to Legs Giving Way	1/375 (0.3%)
Transient Ischaemic Attack	1/375 (0.3%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	1/206 (0.5%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	2/375 (0.5%)
Pulmonary Disorder	1/375 (0.3%)
Surgical and medical procedures
Cataract Surgery	3/375 (0.8%)
Coronary Artery Bypass	1/375 (0.3%)
Vascular disorders
Hypertension	1/375 (0.3%)
Infarction	1/375 (0.3%)
Pulmonary Arterial Thrombosis	1/375 (0.3%)
Other (Not Including Serious) Adverse Events
	Ozurdex® (Dexamethasone Intravitreal Implant)
	Affected / at Risk (%)	# Events
Total	252/375 (67.2%)
Eye disorders
Ocular Hypertension	128/375 (34.1%)
Cataract	124/375 (33.1%)

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.