Macular Edema
Conditions
Brief summary
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
Interventions
DRUG700 μg Dexamethasone
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
OTHERSham
Sham administered in the study eye on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Exclusion criteria
* History of glaucoma, ocular hypertension or optic nerve head change * Any active bacterial, viral, parasitic, or fungal infections in either eye * Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start * History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start * Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start * Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start * Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
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 | Baseline, 6 Months | 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 |
|---|---|---|
| Average Change From Baseline in BCVA in the Study Eye | Baseline, 6 Months | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening. |
| Change From Baseline in BCVA in the Study Eye | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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. A decrease in the number of letters read correctly (negative number) means that vision has worsened. |
| Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 700 μg Dexamethasone 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. | 130 |
| Sham Sham administered in the study eye on Day 1. | 132 |
| Total | 262 |
Baseline characteristics
| Characteristic | 700 μg Dexamethasone | Sham | Total |
|---|---|---|---|
| Age, Customized 45 to 65 years | 94 Participants | 86 Participants | 180 Participants |
| Age, Customized <45 years | 18 Participants | 25 Participants | 43 Participants |
| Age, Customized > 65 years | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Female | 60 Participants | 76 Participants | 136 Participants |
| Sex: Female, Male Male | 70 Participants | 56 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 129 | 15 / 130 |
| serious Total, serious adverse events | 1 / 129 | 2 / 130 |
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: Baseline, 6 Months
Population: Modified Intent-to-Treat: all randomized and treated 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 | 60 Patients |
| Sham | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 31 Patients |
Secondary
Average Change From Baseline in 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) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Time frame: Baseline, 6 Months
Population: Modified Intent-to-Treat: all randomized and treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 μg Dexamethasone | Average Change From Baseline in BCVA in the Study Eye | Baseline | 52.6 Letters Read Correctly | Standard Deviation 10.79 |
| 700 μg Dexamethasone | Average Change From Baseline in BCVA in the Study Eye | Average Change from Baseline Over 6 Months | 6.6 Letters Read Correctly | Standard Deviation 8.98 |
| Sham | Average Change From Baseline in BCVA in the Study Eye | Baseline | 53.1 Letters Read Correctly | Standard Deviation 10.47 |
| Sham | Average Change From Baseline in BCVA in the Study Eye | Average Change from Baseline Over 6 Months | 2.5 Letters Read Correctly | Standard Deviation 9.98 |
Secondary
Change From Baseline in 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) in the study eye. 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. A decrease in the number of letters read correctly (negative number) means that vision has worsened.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Population: Modified Intent-to-Treat: all randomized and treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 2 | 10.6 Letters Read Correctly | Standard Deviation 10.36 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 4 | 5.2 Letters Read Correctly | Standard Deviation 12.79 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 1 | 9.1 Letters Read Correctly | Standard Deviation 8.45 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 5 | 4.4 Letters Read Correctly | Standard Deviation 13.28 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 3 | 7.7 Letters Read Correctly | Standard Deviation 12.66 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 6 | 3.2 Letters Read Correctly | Standard Deviation 15.34 |
| 700 μg Dexamethasone | Change From Baseline in BCVA in the Study Eye | Baseline | 52.6 Letters Read Correctly | Standard Deviation 10.79 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 6 | 4.0 Letters Read Correctly | Standard Deviation 13.73 |
| Sham | Change From Baseline in BCVA in the Study Eye | Baseline | 53.1 Letters Read Correctly | Standard Deviation 10.47 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 1 | 2.0 Letters Read Correctly | Standard Deviation 9.28 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 2 | 1.7 Letters Read Correctly | Standard Deviation 12.29 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 3 | 1.8 Letters Read Correctly | Standard Deviation 12.98 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 4 | 3.3 Letters Read Correctly | Standard Deviation 12.32 |
| Sham | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Month 5 | 3.3 Letters Read Correctly | Standard Deviation 13.04 |
Secondary
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline 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) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Population: Modified Intent-to-Treat: all randomized and treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 1 | 28.7 Percentage of Patients |
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 2 | 34.9 Percentage of Patients |
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 3 | 33.3 Percentage of Patients |
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 4 | 23.3 Percentage of Patients |
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 5 | 22.5 Percentage of Patients |
| 700 μg Dexamethasone | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 6 | 23.3 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 5 | 22.3 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 1 | 5.4 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 4 | 14.6 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 2 | 11.5 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 6 | 20.8 Percentage of Patients |
| Sham | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | Month 3 | 13.1 Percentage of Patients |