Neovascular Macular Degeneration
Conditions
Keywords
PCV
Brief summary
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection
OTHERVisudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Men and women ≥50 years of age * Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center * Greatest linear dimension of the lesion of \< 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA. * An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.
Exclusion criteria
* Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry * Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry * Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT) * History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green. * History of allergy to aflibercept, verteporfin, or their excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) | From Baseline to Week 52 | Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 | At Week 52 | Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 | Baseline to Week 52 | — |
| Time to First Administration of PDT in the Study Eye Before Week 52 | Baseline to Week 52 | — |
| Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye | Baseline to Week 52 | Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
| Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Baseline to Week 52 | Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
| Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Baseline to Week 52 | Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
| Percentage of Subjects Who Never Need Rescue Therapy in the First Year | Baseline to Week 52 | Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps. |
| Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52 | Baseline to Week 52 | Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography. |
| Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52 | Baseline to Week 52 | Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST). |
| Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52 | Baseline to Week 52 | The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight. |
| Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52 | Baseline to Week 52 | Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps. |
| Percentage of Subjects With Complete Polyp Regression at Week 52 | Baseline to Week 52 | Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye. |
| Number of PDT Treatments in the Study Eye Before Week 52 | Baseline to Week 52 | — |
Countries
Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, Taiwan
Participant flow
Recruitment details
The study was conducted at multiple centers in 8 countries worldwide starting from 29 May 2014 (first subject first visit). Primary completion reached on 12 Aug 2016.
Pre-assignment details
Overall, 428 subjects were screened, of them 95 were failed in screening. Remaining 333 subjects received at least one treatment. Of them, 15 subjects discontinued study participation before week 12 and were not randomized. Remaining 318 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy). | 157 |
| Aflibercept + Active PDT Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed | 161 |
| Total | 318 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 3 |
| Overall Study | Death | 3 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | Other reasons | 5 | 4 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 7 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Aflibercept + Sham Photodynamic Therapy (PDT) | Aflibercept + Active PDT |
|---|---|---|---|
| Age, Continuous | 70.6 Years STANDARD_DEVIATION 8.2 | 70.8 Years STANDARD_DEVIATION 8.4 | 70.4 Years STANDARD_DEVIATION 8 |
| Baseline BCVA score | 58.4 Letters STANDARD_DEVIATION 11.4 | 57.7 Letters STANDARD_DEVIATION 11.3 | 59.0 Letters STANDARD_DEVIATION 11.5 |
| Central Subfield Thickness | 346.9 Micrometer STANDARD_DEVIATION 118 | 347.8 Micrometer STANDARD_DEVIATION 118.9 | 346.1 Micrometer STANDARD_DEVIATION 117.5 |
| Sex: Female, Male Female | 96 Participants | 47 Participants | 49 Participants |
| Sex: Female, Male Male | 222 Participants | 110 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 157 | 0 / 161 | 1 / 15 |
| other Total, other adverse events | 59 / 157 | 49 / 161 | 3 / 15 |
| serious Total, serious adverse events | 27 / 157 | 25 / 161 | 4 / 15 |
Outcome results
Primary
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: From Baseline to Week 52
Population: Full Analysis Set (FAS) included all randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) | 10.7 Letters correctly read | Standard Deviation 11.3 |
| Aflibercept + Active PDT | Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) | 10.8 Letters correctly read | Standard Deviation 10.7 |
p-value: 0.54895% CI: [-2.9, 1.6]ANCOVA
Secondary
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: At Week 52
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 | 97.5 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52 | 96.9 Percentage of subjects |
p-value: 0.740295% CI: [-3.1, 4.3]Cochran-Mantel-Haenszel
Other Pre-specified
Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52 | 4.7 Scores on a scale | Standard Deviation 10.3 |
| Aflibercept + Active PDT | Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52 | 7.3 Scores on a scale | Standard Deviation 12.5 |
Comparison: The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.p-value: 0.506995% CI: [-2.9, 1.4]ANCOVA
Other Pre-specified
Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52
Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52 | -137.7 Millimeter | Standard Deviation 116 |
| Aflibercept + Active PDT | Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52 | -143.5 Millimeter | Standard Deviation 110.5 |
Comparison: The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.p-value: 0.835595% CI: [-9.2, 11.3]ANCOVA
Other Pre-specified
Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52
Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52 | -1.3 Square millimeter | Standard Deviation 3.6 |
| Aflibercept + Active PDT | Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52 | -1.2 Square millimeter | Standard Deviation 3.7 |
Comparison: The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.p-value: 0.710995% CI: [-0.9, 0.6]ANCOVA
Other Pre-specified
Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye | 10.7 Letters | Standard Deviation 11.3 |
| Aflibercept + Active PDT | Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye | 10.8 Letters | Standard Deviation 10.7 |
Other Pre-specified
Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 | 5.2 Aflibercept injections | Standard Deviation 1.1 |
| Aflibercept + Active PDT | Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 | 5.1 Aflibercept injections | Standard Deviation 0.8 |
p-value: 0.16495% CI: [-0.1, 0.3]ANCOVA
Other Pre-specified
Number of PDT Treatments in the Study Eye Before Week 52
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Number of PDT Treatments in the Study Eye Before Week 52 | 0.2 PDT administrations | Standard Deviation 0.7 |
| Aflibercept + Active PDT | Number of PDT Treatments in the Study Eye Before Week 52 | 0.2 PDT administrations | Standard Deviation 0.4 |
p-value: 0.068295% CI: [0, 0.2]ANCOVA
Other Pre-specified
Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52 | 12.1 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52 | 14.3 Percentage of subjects |
p-value: 0.842395% CI: [-6.3, 5.1]Cochran-Mantel-Haenszel
Other Pre-specified
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 5 | 73.9 Percentage of subjects |
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 10 | 55.4 Percentage of subjects |
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 15 | 33.1 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 5 | 78.9 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 10 | 57.1 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52 | Gained ≥ 15 | 36.6 Percentage of subjects |
Comparison: Category of Gained ≥ 5p-value: 0.234895% CI: [-14.9, 3.7]Cochran-Mantel-Haenszel
Comparison: Category of Gained ≥ 10p-value: 0.687795% CI: [-13.1, 8.6]Cochran-Mantel-Haenszel
Comparison: Category of Gained ≥ 15p-value: 0.455695% CI: [-14.5, 6.5]Cochran-Mantel-Haenszel
Other Pre-specified
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 5 | 7.0 Percentage of subjects |
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 10 | 3.8 Percentage of subjects |
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 15 | 2.5 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 5 | 5.6 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 10 | 3.1 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52 | Lost ≥ 15 | 3.1 Percentage of subjects |
Comparison: Category of Lost ≥ 5p-value: 0.537295% CI: [-3.7, 7.2]Cochran-Mantel-Haenszel
Comparison: Category of Lost ≥ 10p-value: 0.756995% CI: [-3.4, 4.7]Cochran-Mantel-Haenszel
Comparison: Category of Lost ≥ 15p-value: 0.740295% CI: [-4.3, 3.1]Cochran-Mantel-Haenszel
Other Pre-specified
Percentage of Subjects Who Never Need Rescue Therapy in the First Year
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects Who Never Need Rescue Therapy in the First Year | 87.9 Percentage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects Who Never Need Rescue Therapy in the First Year | 85.7 Percentage of subjects |
Other Pre-specified
Percentage of Subjects With Complete Polyp Regression at Week 52
Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.
Time frame: Baseline to Week 52
Population: FAS with evaluable subjects for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Percentage of Subjects With Complete Polyp Regression at Week 52 | 38.9 Percetage of subjects |
| Aflibercept + Active PDT | Percentage of Subjects With Complete Polyp Regression at Week 52 | 44.8 Percetage of subjects |
p-value: 0.324495% CI: [-17.8, 5.9]Cochran-Mantel-Haenszel
Other Pre-specified
Time to First Administration of PDT in the Study Eye Before Week 52
Time frame: Baseline to Week 52
Population: FAS
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aflibercept + Sham Photodynamic Therapy (PDT) | Time to First Administration of PDT in the Study Eye Before Week 52 | 131.2 Days |
| Aflibercept + Active PDT | Time to First Administration of PDT in the Study Eye Before Week 52 | 128.2 Days |