Age-Related Maculopathy, Choroidal Neovascularization
Conditions
Brief summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.
Interventions
DRUGdexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
BIOLOGICALranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD * Central retinal thickness ≥ 300 µm * Visual acuity between 20/400 and 20/32 * Eligible for Anti-VEGF therapy
Exclusion criteria
* Previous treatment for CNV due to AMD * High eye pressure * Glaucoma * Uncontrolled systemic disease * Known allergy to the study medications * Recent eye surgery or injections in the eye * Female subjects that are of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 | Baseline, Week 4 | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 | Baseline, Week 26 | 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. |
| Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Baseline, Week 26 | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased \>=10%), Unchanged (Leakage area changed \< 10%) and Worsened (Leakage area increased \>=10%). |
Countries
Australia, Philippines, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 700 µg Dexamethasone + Ranibizumab 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | 700 µg Dexamethasone + Ranibizumab |
|---|---|
| Age Continuous | 72.3 Years STANDARD_DEVIATION 10.43 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 44 |
| serious Total, serious adverse events | 6 / 44 |
Outcome results
Primary
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.
Time frame: Baseline, Week 4
Population: Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 µg Dexamethasone + Ranibizumab | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 | Baseline | 360.9 Microns | Standard Deviation 69.23 |
| 700 µg Dexamethasone + Ranibizumab | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 | Change from baseline at Week 4 | -62.0 Microns | Standard Deviation 78.68 |
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26
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.
Time frame: Baseline, Week 26
Population: Intent to treat population consisting of all enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 700 µg Dexamethasone + Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 | Baseline | 46.5 Number of letters | Standard Deviation 17.73 |
| 700 µg Dexamethasone + Ranibizumab | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 | Change from baseline at Week 26 | 4.5 Number of letters | Standard Deviation 9.62 |
Secondary
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26
Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased \>=10%), Unchanged (Leakage area changed \< 10%) and Worsened (Leakage area increased \>=10%).
Time frame: Baseline, Week 26
Population: Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 700 µg Dexamethasone + Ranibizumab | Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Improved | 74.4 Percentage of participants |
| 700 µg Dexamethasone + Ranibizumab | Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Unchanged | 18.6 Percentage of participants |
| 700 µg Dexamethasone + Ranibizumab | Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Worsened | 7.0 Percentage of participants |