Back to resultsSafety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Primary Purpose
Retinal Vein Occlusion, Macular Edema
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
dexamethasone intravitreal implant
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of branch retinal vein occlusion in at least one eye
- Visual acuity between 20/400 to 20/40
Exclusion Criteria:
- Active eye infection
- Ocular hypertension which is not controlled on monotherapy (one medication)
- Anticipated need for eye surgery during the study
- Cataract surgery in either eye within 3 months
- Eye surgery including laser of any type within 6 months
- Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
- Use of ocular steroids within 3 months
- Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ozurdex®
Lucentis®
Arm Description
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Outcomes
Primary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA)
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. 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 change from Baseline (more letters read correctly) indicates improvement.
Secondary Outcome Measures
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
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 Month 12. A negative change from Baseline indicates improvement.
Percentage of Patients With 15-or-More Letter Improvement in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. 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 improvement in the number of letters read means that the vision has improved.
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time to BCVA Improvement of 15-or-More Letters
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01427751
Brief Title
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 11, 2011 (Actual)
Primary Completion Date
November 4, 2014 (Actual)
Study Completion Date
November 4, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozurdex®
Arm Type
Active Comparator
Arm Description
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Arm Title
Lucentis®
Arm Type
Active Comparator
Arm Description
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Intervention Type
Drug
Intervention Name(s)
dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex®
Intervention Description
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Description
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. 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 change from Baseline (more letters read correctly) indicates improvement.
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
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 Month 12. A negative change from Baseline indicates improvement.
Time Frame
Baseline, Month 12
Title
Percentage of Patients With 15-or-More Letter Improvement in BCVA
Description
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. 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 improvement in the number of letters read means that the vision has improved.
Time Frame
Baseline, Month 12
Title
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
Description
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time Frame
Baseline, Month 12
Title
Time to BCVA Improvement of 15-or-More Letters
Description
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Time Frame
12 Months
Title
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Description
The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Time Frame
Baseline, Month 12
Title
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Description
Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of branch retinal vein occlusion in at least one eye
Visual acuity between 20/400 to 20/40
Exclusion Criteria:
Active eye infection
Ocular hypertension which is not controlled on monotherapy (one medication)
Anticipated need for eye surgery during the study
Cataract surgery in either eye within 3 months
Eye surgery including laser of any type within 6 months
Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
Use of ocular steroids within 3 months
Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Paris
Country
France
City
Munich
Country
Germany
City
Tel Aviv
Country
Israel
City
Milan
Country
Italy
City
Madrid
Country
Spain
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29631435
Citation
Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.
Results Reference
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Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
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