Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
Interventions
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone intravitreal implant administered on Day 0.
OTHERSham Injection
Sham injection on Day 0.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 18 years of age or older with macular edema resulting from retinal vein occlusion * Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * Visual acuity in other eye no worse than 20/200 Key
Exclusion criteria
* Known anticipated need for ocular surgery within next 12 months * History of glaucoma or current high eye pressure requiring more than 1 medication * Diabetic retinopathy * Uncontrolled systemic disease * Known steroid-responder * Use of systemic steroids * Use of warfarin/heparin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | Day 180 | BCVA is measured 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). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Retinal Thickness in the Study Eye | Baseline, Day 90, Day 180 | 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 change from baseline indicates an improvement. |
| Percentage of Patients With a Change From Baseline in BCVA by Category | Baseline, Day 90 | BCVA is measured 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). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening. |
Countries
Brazil, Canada, Colombia, Hong Kong, India, Italy, New Zealand, Poland, Singapore, South Korea, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Patients were randomly assigned during the double-blind period of the study to treatment with 700 µg dexamethasone, 350 µg dexamethasone, or sham injection on Day 0. Patients who qualified to continue in the open-label period of the study received 700 µg dexamethasone on Day 180.
Participants by arm
| Arm | Count |
|---|---|
| 700 µg Dexamethasone 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. | 226 |
| 350 µg Dexamethasone Followed by 700 µg Dexamethasone 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. | 218 |
| Sham Injection Followed by 700 µg Dexamethasone Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. | 224 |
| Total | 668 |
Baseline characteristics
| Characteristic | Total | 700 µg Dexamethasone | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | Sham Injection Followed by 700 µg Dexamethasone |
|---|---|---|---|---|
| Age, Customized 45-65 years | 328 participants | 109 participants | 108 participants | 111 participants |
| Age, Customized <45 years | 42 participants | 14 participants | 15 participants | 13 participants |
| Age, Customized >65 years | 298 participants | 103 participants | 95 participants | 100 participants |
| Sex: Female, Male Female | 318 Participants | 115 Participants | 102 Participants | 101 Participants |
| Sex: Female, Male Male | 350 Participants | 111 Participants | 116 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 168 / 225 | 145 / 215 | 94 / 221 |
| serious Total, serious adverse events | 16 / 225 | 7 / 215 | 17 / 221 |
Outcome results
Primary
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured 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). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
Time frame: Day 180
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 700 µg Dexamethasone | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 53 Number of Participants |
| 350 µg Dexamethasone | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 48 Number of Participants |
| Sham Injection | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 38 Number of Participants |
Secondary
Change From Baseline in Retinal Thickness in the Study Eye
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 change from baseline indicates an improvement.
Time frame: Baseline, Day 90, Day 180
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 90 | -215.6 Microns (µm) | Standard Deviation 207.62 |
| 700 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Baseline | 573.6 Microns (µm) | Standard Deviation 189.08 |
| 700 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 180 | -132.1 Microns (µm) | Standard Deviation 207.2 |
| 350 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 90 | -205.5 Microns (µm) | Standard Deviation 216.25 |
| 350 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Baseline | 566.6 Microns (µm) | Standard Deviation 219.63 |
| 350 µg Dexamethasone | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 180 | -150.5 Microns (µm) | Standard Deviation 220.78 |
| Sham Injection | Change From Baseline in Retinal Thickness in the Study Eye | Baseline | 542.5 Microns (µm) | Standard Deviation 185.64 |
| Sham Injection | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 180 | -127.4 Microns (µm) | Standard Deviation 197.77 |
| Sham Injection | Change From Baseline in Retinal Thickness in the Study Eye | Change from Baseline at Day 90 | -91.1 Microns (µm) | Standard Deviation 191.85 |
Secondary
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured 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). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
Time frame: Baseline, Day 90
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 4.4 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 25.7 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 21.2 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 45.1 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 3.5 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 26.6 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 25.7 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 39.0 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 6.4 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 2.3 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 8.0 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 11.2 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 13.8 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 29.9 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 37.1 Percentage of Patients |
Secondary
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured 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). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
Time frame: Baseline, Day 180
Population: Intent-to-Treat: all randomized patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 23.5 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 8.0 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 27.0 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 6.6 Percentage of Patients |
| 700 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 35.0 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 5.0 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 21.6 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 33.9 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 28.9 Percentage of Patients |
| 350 µg Dexamethasone | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 10.6 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Improvement | 28.6 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Worsening | 12.1 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥5 and <15 Letters Worsening | 13.8 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | ≥15 Letters Improvement | 17.0 Percentage of Patients |
| Sham Injection | Percentage of Patients With a Change From Baseline in BCVA by Category | No Change (Between -5 to +5 Letters) | 28.6 Percentage of Patients |