Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004464-54 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept + Sham PDT | Experimental | 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) |
|
| Aflibercept + Active PDT | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Eylea is administered as an intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool | New South Wales | 2170 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903075 | Derived | Teo KYC, Yoon YH, Honda S, Park KH, Takahashi H, Ideta R, Sekiryu T, Hirata A, Obana A, Mori R, Chen SJ, Chee C, Wong JG, Lai TYY, Wong I, Fung N, Lee WK, Terasaki H, Chen SC, Miyatani T, Iida T, Obata R, Machewitz T, Leal S, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the PLANET Study. Ophthalmol Ther. 2026 Jun;15(6):1907-1924. doi: 10.1007/s40123-026-01366-5. Epub 2026 Mar 28. | |
| 29801063 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Visudyne | Other | Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser) |
|
| At Week 52 |
| Baseline to Week 52 |
| Number of PDT Treatments in the Study Eye Before Week 52 | Baseline to Week 52 |
| 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 | 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. | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| 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). | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| 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. | Baseline to Week 52 |
| Strathfield |
| New South Wales |
| 2135 |
| Australia |
| Westmead | New South Wales | 2145 | Australia |
| East Melbourne | Victoria | 3002 | Australia |
| Parramatta | 2150 | Australia |
| München | 80336 | Germany |
| Hong Kong | Hong Kong |
| Kowloon | Hong Kong |
| Budapest | 1082 | Hungary |
| Budapest | 1106 | Hungary |
| Budapest | 1133 | Hungary |
| Debrecen | 4032 | Hungary |
| Nagoya | Aichi-ken | 466-8560 | Japan |
| Urayasu | Chiba | 279-0021 | Japan |
| Ōgaki | Gifu | 503-0015 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Asahikawa | Hokkaido | 078-8510 | Japan |
| Sapporo | Hokkaido | 060-8604 | Japan |
| Amagasaki | Hyōgo | 660-8550 | Japan |
| Kobe | Hyōgo | 650-0017 | Japan |
| Kita | Kagawa-ken | 761-0793 | Japan |
| Tsu | Mie-ken | 514-8507 | Japan |
| Kashihara | Nara | 634-8522 | Japan |
| Hirakata | Osaka | 573-1191 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu | Shizuoka | 430-8558 | Japan |
| Shimotsuke | Tochigi | 329-0498 | Japan |
| Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Meguro-ku | Tokyo | 152-8902 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |
| Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Akita | 010-8543 | Japan |
| Aomori | 030-8553 | Japan |
| Chiba | 260-8677 | Japan |
| Fukuoka | 812-0011 | Japan |
| Fukuoka | 812-8582 | Japan |
| Fukushima | 960-1295 | Japan |
| Kumamoto | 860-0027 | Japan |
| Kyoto | 602-0841 | Japan |
| Kyoto | 606-8507 | Japan |
| Nagasaki | 852-8511 | Japan |
| Okayama | 700-8558 | Japan |
| Osaka | 545-8586 | Japan |
| Tokushima | 770-8503 | Japan |
| Wakayama | 641-8510 | Japan |
| Singapore | 119074 | Singapore |
| Singapore | 168751 | Singapore |
| Seongnam-si | Gyeonggido | 463-707 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 05505 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 153-950 | South Korea |
| Changhua | Changhua | 500 | Taiwan |
| Kaohsiung City | 81362 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taipei | 10449 | Taiwan |
| Taipei | 11217 | Taiwan |
| Taipei | Taiwan |
| Derived |
| Lee WK, Iida T, Ogura Y, Chen SJ, Wong TY, Mitchell P, Cheung GCM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):786-793. doi: 10.1001/jamaophthalmol.2018.1804. |
| FG001 |
| 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 |
| FG002 | Aflibercept (Non-randomized) | Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics is reported in Full analysis set which included all randomized subjects (N=318).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline BCVA score | 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 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. | Mean | Standard Deviation | Letters |
| ||||||||||||||
| Central Subfield Thickness | Mean | Standard Deviation | Micrometer |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set (FAS) included all randomized subjects | Posted | Mean | Standard Deviation | Letters correctly read | From Baseline to Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | Percentage of subjects | At Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | Percentage of subjects | Baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of PDT Treatments in the Study Eye Before Week 52 | FAS | Posted | Mean | Standard Deviation | PDT administrations | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52 | FAS with evaluable subjects for this outcome measure. | Posted | Mean | Standard Deviation | Aflibercept injections | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to First Administration of PDT in the Study Eye Before Week 52 | FAS | Posted | Mean | Full Range | Days | Baseline to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Mean | Standard Deviation | Letters | Baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | Percentage of subjects | Baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | Percentage of subjects | Baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with evaluable subjects for this outcome measure. | Posted | Number | Percetage of subjects | Baseline to Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with evaluable subjects for this outcome measure. | Posted | Mean | Standard Deviation | Square millimeter | Baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | FAS with evaluable subjects for this outcome measure. | Posted | Mean | Standard Deviation | Millimeter | Baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with evaluable subjects for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with evaluable subjects for this outcome measure. | Posted | Number | Percentage of subjects | Baseline to Week 52 |
|
From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept + Sham PDT | Subjects 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 assessed for the rescue treatment and randomized to receive Aflibercept injection plus sham 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. | 3 | 157 | 27 | 157 | 59 | 157 |
| EG001 | Aflibercept + Active PDT | Subjects 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 assessed for the rescue treatment and 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. | 0 | 161 | 25 | 161 | 49 | 161 |
| EG002 | Aflibercept (Non-randomized) | Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization. | 1 | 15 | 4 | 15 | 3 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Retinal pigment epithelial tear | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Afferent loop syndrome | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Gastric adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Senile dementia | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Transcatheter arterial chemoembolisation | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Retinal pigment epithelial tear | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|