Macular Edema, Retinal Vein Occlusion
Conditions
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).
Interventions
DRUGdexamethasone intravitreal implant
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.
BIOLOGICALranibizumab
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, Month 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With 15-or-More Letter Improvement in BCVA | Baseline, Month 12 | 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 | Baseline, Month 12 | 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). |
| Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | Baseline, Month 12 | 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. |
| Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | Baseline, Month 12 | 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 | 12 Months | 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 to BCVA Improvement of 15-or-More Letters | 12 Months | 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. |
Countries
France, Germany, Israel, Italy, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ozurdex® Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. | 154 |
| Lucentis® Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria. | 153 |
| Total | 307 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 2 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | No further treatment benefit expected | 5 | 1 |
| Overall Study | Other miscellaneous reasons | 6 | 4 |
| Overall Study | Protocol Violation | 6 | 4 |
| Overall Study | Withdrawal of consent | 2 | 2 |
Baseline characteristics
| Characteristic | Ozurdex® | Lucentis® | Total |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 10.58 | 65.5 years STANDARD_DEVIATION 12.04 | 67.0 years STANDARD_DEVIATION 11.41 |
| Sex: Female, Male Female | 62 Participants | 66 Participants | 128 Participants |
| Sex: Female, Male Male | 92 Participants | 87 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 127 / 153 | 104 / 150 |
| serious Total, serious adverse events | 12 / 153 | 16 / 150 |
Outcome results
Primary
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.
Time frame: Baseline, Month 12
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline (n=153,153) | 56.6 letters | Standard Deviation 10.89 |
| Ozurdex® | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Change from Baseline at Month 12 (n=153,151) | 7.9 letters | Standard Deviation 14.42 |
| Lucentis® | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline (n=153,153) | 59.2 letters | Standard Deviation 10.92 |
| Lucentis® | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Change from Baseline at Month 12 (n=153,151) | 16.9 letters | Standard Deviation 12.08 |
Secondary
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.
Time frame: Baseline, Month 12
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® | Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | Baseline (n=149, 149) | 553.2 microns | Standard Deviation 170.15 |
| Ozurdex® | Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | Change from Baseline at Month 12 (n=140,144) | -219.2 microns | Standard Deviation 180.51 |
| Lucentis® | Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | Baseline (n=149, 149) | 561.0 microns | Standard Deviation 188.93 |
| Lucentis® | Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | Change from Baseline at Month 12 (n=140,144) | -253.5 microns | Standard Deviation 197.08 |
Secondary
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.
Time frame: Baseline, Month 12
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ozurdex® | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | Baseline (n=143,139) | 78.1 score on a scale | Standard Deviation 16.58 |
| Ozurdex® | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | Change from Baseline at Month 12 (n=143, 139) | 3.5 score on a scale | Standard Deviation 12.21 |
| Lucentis® | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | Baseline (n=143,139) | 80.7 score on a scale | Standard Deviation 14.34 |
| Lucentis® | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | Change from Baseline at Month 12 (n=143, 139) | 6.6 score on a scale | Standard Deviation 13.45 |
Secondary
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.
Time frame: 12 Months
Population: Intent-to-treat population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozurdex® | Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure | 4.5 percentage of participants |
| Lucentis® | Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure | 0.7 percentage of participants |
Secondary
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.
Time frame: Baseline, Month 12
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozurdex® | Percentage of Patients With 15-or-More Letter Improvement in BCVA | 33.8 percentage of participants |
| Lucentis® | Percentage of Patients With 15-or-More Letter Improvement in BCVA | 59.5 percentage of participants |
Secondary
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 frame: Baseline, Month 12
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ozurdex® | Percentage of Patients With a 15-or-More Letter Decrease in BCVA | 9.1 percentage of participants |
| Lucentis® | Percentage of Patients With a 15-or-More Letter Decrease in BCVA | 0.7 percentage of participants |
Secondary
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.
Time frame: 12 Months
Population: Participants from the intent-to-treat population, all randomized participants, with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ozurdex® | Time to BCVA Improvement of 15-or-More Letters | 73.7 days | Standard Deviation 79.68 |
| Lucentis® | Time to BCVA Improvement of 15-or-More Letters | 82.0 days | Standard Deviation 93.78 |