Age-Related Maculopathy, Subfoveal Choroidal Neovascularization
Conditions
Brief summary
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
Interventions
DRUG700 ug dexamethasone
Intravitreal injection of 700 ug dexamethasone into study eye
BIOLOGICALranibizumab
Intravitreal injection of ranibizumab into study eye
OTHERsham
Sham needle-less injection administered in the study eye
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received at least 2 and no more than 3 monthly Lucentis or Avastin injections * Last Lucentis or Avastin was injected approximately 4 weeks prior to screening * Visual acuity between 20/320 and 20/40
Exclusion criteria
* Active ocular infection * Contraindication to pupil dilation in either eye * Eye surgery including cataract surgery and/or laser of any type within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Baseline, Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 | Baseline, Month 12 | 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. |
| Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography | Baseline, Month 12 | 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 Month 12. |
| Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography | Baseline, Month 12 | 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 was performed on the study eye after dilation at baseline and Week 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone and Ranibizumab Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye. | 2 |
| Ranibizumab and Sham Intravitreal injection of ranibizumab and sham into study eye. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Total | Dexamethasone and Ranibizumab | Ranibizumab and Sham |
|---|---|---|---|
| Age, Customized >=80 years | 3 Participants | 1 Participants | 2 Participants |
| Age, Customized Between 50 and 80 years | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
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, Month 12
Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.
Secondary
Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
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 was performed on the study eye after dilation at baseline and Week 12.
Time frame: Baseline, Month 12
Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.
Secondary
Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
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 Month 12.
Time frame: Baseline, Month 12
Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.
Secondary
The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
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, Month 12
Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.