Diabetic Macular Edema, Vitrectomy
Conditions
Brief summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
Interventions
DRUGDexamethasone
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older with diabetic macular edema * History of vitrectomy * Central retinal thickness ≥ 275 µm * Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
Exclusion criteria
* Known anticipated need for ocular surgery during the study period * History of glaucoma or current high eye pressure requiring more than 1 medication * Uncontrolled systemic disease * Known allergy to the study medication * Known steroid-responder * Use of systemic steroids * Female subjects that are pregnant, nursing or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Retinal Thickness in the Study Eye | Baseline, Week 26 | Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Week 26 | BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening. |
| Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye | Baseline, Week 26 | BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening. |
| Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Baseline, Week 26 | Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased ≥ 10%). |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 700 µg Dexamethasone Implant 700 µg dexamethasone implant in the study eye at Day 1 | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | 700 µg Dexamethasone Implant |
|---|---|
| Age, Customized 18 to 65 years | 37 Participants |
| Age, Customized >65 years | 19 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 55 / 55 |
| serious Total, serious adverse events | 14 / 55 |
Outcome results
Primary
Change From Baseline in Central Retinal Thickness in the Study Eye
Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: Baseline, Week 26
Population: Intent to Treat: all enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 µg Dexamethasone Implant | Change From Baseline in Central Retinal Thickness in the Study Eye | Baseline | 403.4 Microns | Standard Deviation 117.1 |
| 700 µg Dexamethasone Implant | Change From Baseline in Central Retinal Thickness in the Study Eye | Change from Baseline at Week 26 | -38.9 Microns | Standard Deviation 96.93 |
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
Time frame: Baseline, Week 26
Population: Intent to Treat: all enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 µg Dexamethasone Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 54.5 Letters Read Correctly | Standard Deviation 12.6 |
| 700 µg Dexamethasone Implant | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 26 | 3.0 Letters Read Correctly | Standard Deviation 11.11 |
Secondary
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Time frame: Baseline, Week 26
Population: Intent to treat: all enrolled patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 700 µg Dexamethasone Implant | Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye | 21.4 Percentage of Patients |
Secondary
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased ≥ 10%).
Time frame: Baseline, Week 26
Population: Intent to Treat: all enrolled patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 700 µg Dexamethasone Implant | Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Worsened at Week 26 | 9.5 Percentage of Patients |
| 700 µg Dexamethasone Implant | Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Improved at Week 26 | 33.3 Percentage of Patients |
| 700 µg Dexamethasone Implant | Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye | Unchanged at Week 26 | 57.1 Percentage of Patients |