A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01571557
• Collaborator: (none)
• Enrollment: 573
• Location: 1
• Actual Duration (Months): 26
• Patients Per Site Per Month: 22

Study Details

Study Description

Brief Summary

This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Retinal Vein Occlusion	Drug: dexamethasone 700 ug intravitreal implant

Study Design

• Study Type: Observational
• Actual Enrollment: 573 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Actual Study Start Date: Apr 30, 2012
• Actual Primary Completion Date: Mar 31, 2014
• Actual Study Completion Date: Jun 30, 2014

Arms and Interventions

Arm	Intervention/Treatment
OZURDEX® OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.	Drug: dexamethasone 700 ug intravitreal implant; dexamethasone 700 ug intravitreal implant administered according to standard of care.; Other Names: OZURDEX®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [Baseline, Week 12]

   BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.

Secondary Outcome Measures

1. Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye [Baseline, 48 Weeks]

   BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.

2. Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye [Baseline, 48 Weeks]

   BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.

3. Mean Change From Baseline in Central Retinal Thickness [Baseline, Week 24]

   Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline 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:

• Diagnosis of macular edema following retinal vein occlusion

• Prescribed OZURDEX®

Exclusion Criteria:

• Previous treatment with OZURDEX®

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01571557
• Other Study ID Numbers: MAF/AGN/OPH/RET/011
• First Posted: Apr 5, 2012
• Last Update Posted: Apr 19, 2019
• Last Verified: Apr 1, 2019

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

Study Results

Participant Flow

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Period Title: Overall Study
STARTED	573
COMPLETED	573
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Overall Participants	573
Age, Customized (Count of Participants)
31 to 40 years	4 0.7%
41 to 50 years	13 2.3%
51 to 60 years	69 12%
61 to 70 years	127 22.2%
71 to 80 years	235 41%
81 to 90 years	119 20.8%
91 to 100 years	6 1%
Sex: Female, Male (Count of Participants)
Female	286 49.9%
Male	287 50.1%

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 following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

All enrolled patients with complete data at this time point

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Measure Participants	351
Baseline	52.431 (18.929)
Change from Baseline at Week 12	7.774 (14.986)

2. Secondary Outcome

Title	Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
Description	BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.
Time Frame	Baseline, 48 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Measure Participants	573
Number [Percentage of Patients]	46.60

3. Secondary Outcome

Title	Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
Description	BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.
Time Frame	Baseline, 48 Weeks

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Measure Participants	573
Number [Percentage of Patients]	36.47

4. Secondary Outcome

Title	Mean Change From Baseline in Central Retinal Thickness
Description	Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

All enrolled patients with complete data at this time point

Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
Measure Participants	343
Baseline	501.18 (169.30)
Change from Baseline at Week 24 (N=138)	-61.75 (192.28)

Adverse Events

Time Frame	Adverse events (AEs) and serious adverse events (SAEs) were collected from the time of the first OZURDEX® injection through the final follow-up visit for each patient.
Adverse Event Reporting Description	All enrolled patients were used to assess AEs and SAEs.
Arm/Group Title	OZURDEX®
Arm/Group Description	OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
All Cause Mortality
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	1/573 (0.2%)
Eye disorders
Glaucoma	1/573 (0.2%)
Other (Not Including Serious) Adverse Events
	OZURDEX®
	Affected / at Risk (%)	# Events
Total	33/573 (5.8%)
Eye disorders
Intraocular Pressure Increased	33/573 (5.8%)

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.