ARIES: Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT02581891
Collaborator
Regeneron Pharmaceuticals (Industry)
287
39
2
41.2
7.4
0.2
Study Details
Study Description
Brief Summary
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The T&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.
To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T&E regimen with intravitreal aflibercept in subjects with nAMD.
Study Design
Study Type:
Interventional
Actual Enrollment
:
287 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)
Actual Study Start Date
:
Nov 19, 2015
Actual Primary Completion Date
:
Apr 26, 2019
Actual Study Completion Date
:
Apr 26, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early-start T&E / Arm 1 Early-start T&E arm: test group, early treatment individualization |
Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria
|
| Active Comparator: Late-start T&E / Arm 2 Late-start T&E arm; per label, control group, treatment individualization after Year 1 |
Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria
|
Outcome Measures
Primary Outcome Measures
- Change in BCVA as Measured by the ETDRS Letter Score [From Week 16 to Week 104]
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
Secondary Outcome Measures
- Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline [at Week 104]
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
- Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52 [from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52]
BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.
- Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline [At week 52]
Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
- Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline [At Week 52 and Week 104]
Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.
- Change in Central Retinal Thickness (CRT) [From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104]
CRT were evaluated using spectral domain Optical coherence tomograph (OCT).
- Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104 [At Week 52 and Week 104]
- Duration of Last Treatment Interval [Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination]
- Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval [at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men and women ≥ 50 years of age.
-
Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
-
ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
-
The area of CNV must occupy at least 50% of the total lesion.
Exclusion Criteria:
-
Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
-
Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
-
Prior treatment with anti-VEGF agents as follows:
-
Prior treatment with anti-VEGF therapy in the study eye is not allowed
-
Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
-
Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
-
Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
-
Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
-
Scar or fibrosis making up >50% of the total lesion in the study eye.
-
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
-
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Strathfield | New South Wales | Australia | 2135 | |
| 2 | Sydney | New South Wales | Australia | 2000 | |
| 3 | Westmead | New South Wales | Australia | 2145 | |
| 4 | East Melbourne | Victoria | Australia | 3002 | |
| 5 | Launceston | Australia | 7249 | ||
| 6 | Hamilton | Ontario | Canada | L8G 5E4 | |
| 7 | Ottawa | Ontario | Canada | K2B 7E9 | |
| 8 | Boisbriand | Quebec | Canada | J7H 1S6 | |
| 9 | Creteil Cedex | France | 94010 | ||
| 10 | Nice cedex 1 | France | 06006 | ||
| 11 | Freiburg | Baden-Württemberg | Germany | 79106 | |
| 12 | Tübingen | Baden-Württemberg | Germany | 72076 | |
| 13 | Hannover | Niedersachsen | Germany | 30625 | |
| 14 | Bonn | Nordrhein-Westfalen | Germany | 53105 | |
| 15 | Köln | Nordrhein-Westfalen | Germany | 50924 | |
| 16 | Sulzbach | Saarland | Germany | 66280 | |
| 17 | Chemnitz | Sachsen | Germany | 09116 | |
| 18 | Berlin | Germany | 10713 | ||
| 19 | Budapest | Hungary | 1062 | ||
| 20 | Budapest | Hungary | 1085 | ||
| 21 | Budapest | Hungary | 1106 | ||
| 22 | Budapest | Hungary | 1115 | ||
| 23 | Budapest | Hungary | 1125 | ||
| 24 | Budapest | Hungary | 1133 | ||
| 25 | Debrecen | Hungary | 4032 | ||
| 26 | Pecs | Hungary | 7621 | ||
| 27 | Szombathely | Hungary | 9700 | ||
| 28 | Roma | Lazio | Italy | 00198 | |
| 29 | Milano | Lombardia | Italy | 20132 | |
| 30 | Milano | Lombardia | Italy | 20157 | |
| 31 | Padova | Veneto | Italy | 35128 | |
| 32 | Oviedo | Asturias | Spain | 33012 | |
| 33 | Madrid | Spain | |||
| 34 | Zaragoza | Spain | 50009 | ||
| 35 | Canterbury | Kent | United Kingdom | CT1 3NG | |
| 36 | Bristol | United Kingdom | BS1 2LX | ||
| 37 | Liverpool | United Kingdom | L7 8XP | ||
| 38 | London | United Kingdom | EC1V 2PD | ||
| 39 | Oxford | United Kingdom | OX3 9DU |
Sponsors and Collaborators
- Bayer
- Regeneron Pharmaceuticals
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02581891
Other Study ID Numbers:
- 17508
- 2014-003132-39
First Posted:
Oct 21, 2015
Last Update Posted:
May 21, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Bayer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study was conducted from 19-Nov-2015 (First Patient First Visit) to 26-Apr-2019 (Last Patient Last Visit). |
|---|---|
| Pre-assignment Detail | A total of 443 participants were screened in this study. Of these, 156 participants were screening failures and did not enter the treatment period. Of the 287 treated participants, 16 were treated during the initiation phase, but were not randomized to a treatment arm after the initiation phase. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Period Title: Overall Study | ||
| STARTED | 135 | 136 |
| Completed Treatment | 120 | 117 |
| COMPLETED | 119 | 117 |
| NOT COMPLETED | 16 | 19 |
Baseline Characteristics
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm | Total |
|---|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | Total of all reporting groups |
| Overall Participants | 135 | 136 | 271 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
76
(8.8)
|
76.9
(8.2)
|
76.5
(8.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
81
60%
|
73
53.7%
|
154
56.8%
|
| Male |
54
40%
|
63
46.3%
|
117
43.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
2.2%
|
7
5.1%
|
10
3.7%
|
| Not Hispanic or Latino |
126
93.3%
|
122
89.7%
|
248
91.5%
|
| Unknown or Not Reported |
6
4.4%
|
7
5.1%
|
13
4.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
1.5%
|
1
0.7%
|
3
1.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
0.7%
|
0
0%
|
1
0.4%
|
| White |
131
97%
|
127
93.4%
|
258
95.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
0.7%
|
8
5.9%
|
9
3.3%
|
| Baseline BCVA letters scores (study eye) (letters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [letters] |
60.2
(12.1)
|
61.3
(10.8)
|
60.8
(11.4)
|
| Baseline CRT (μm) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [μm] |
443.7
(120.0)
|
448.3
(133.1)
|
446.0
(126.4)
|
Outcome Measures
| Title | Change in BCVA as Measured by the ETDRS Letter Score |
|---|---|
| Description | BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning. |
| Time Frame | From Week 16 to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Mean (Standard Deviation) [Letters correctly read] |
-2.1
(11.4)
|
-0.4
(8.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Early-start T&E Arm, Late-start T&E Arm |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority margin is set to 5 letters. | |
| Statistical Test of Hypothesis | p-Value | 0.0162 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -2.0199 | |
| Confidence Interval |
(2-Sided) 95% -4.7470 to 0.7073 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.3833 |
|
| Estimation Comments | ||
| Title | Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline |
|---|---|
| Description | Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter. |
| Time Frame | at Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Number [Percentage] |
93.4
|
96.2
|
| Title | Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52 |
|---|---|
| Description | BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning. |
| Time Frame | from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| From baseline to Week 52 |
7.8
(9.4)
|
10.2
(9.3)
|
| From baseline to Week 104 |
4.3
(13.4)
|
7.9
(11.9)
|
| Week 16 |
66.7
(13.0)
|
69.6
(11.6)
|
| From Week 16 to Week 52 |
1.3
(6.4)
|
2.0
(5.3)
|
| Title | Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline |
|---|---|
| Description | Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter. |
| Time Frame | At week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Number [Percentage] |
100.0
|
100.0
|
| Title | Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline |
|---|---|
| Description | Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter. |
| Time Frame | At Week 52 and Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Week 52 |
19.8
|
27.9
|
| Week 104 |
18.9
|
22.1
|
| Title | Change in Central Retinal Thickness (CRT) |
|---|---|
| Description | CRT were evaluated using spectral domain Optical coherence tomograph (OCT). |
| Time Frame | From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| From baseline to Week 52 |
-164.9
(117.3)
|
-167.1
(117.1)
|
| From baseline to Week 104 |
-161.6
(135.6)
|
-158.6
(125.1)
|
| Week 16 |
321.4
(93.4)
|
322.5
(104.0)
|
| From Week 16 to Week 52 |
-28.5
(56.3)
|
-28.7
(54.0)
|
| From Week 16 to Week 104 |
-25.1
(68.9)
|
-20.2
(70.0)
|
| Title | Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104 |
|---|---|
| Description | |
| Time Frame | At Week 52 and Week 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Week 52 |
7.1
(0.8)
|
8.0
(0.2)
|
| Week 104 |
12.0
(2.3)
|
13.0
(1.8)
|
| Title | Duration of Last Treatment Interval |
|---|---|
| Description | |
| Time Frame | Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| Mean (Standard Deviation) [Weeks] |
11.5
(3.7)
|
11.4
(3.7)
|
| Title | Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval |
|---|---|
| Description | |
| Time Frame | at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (Per-protocol set): all participants in the FAS (full analysis set) without any major protocol deviation. |
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm |
|---|---|---|
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. |
| Measure Participants | 106 | 104 |
| <8 weeks |
5.7
|
7.7
|
| 8 weeks |
27.4
|
29.8
|
| 10 weeks |
19.8
|
10.6
|
| 12 weeks |
8.5
|
13.5
|
| 14 weeks |
8.5
|
11.5
|
| 16 weeks |
25.5
|
25.0
|
| >16 weeks |
4.7
|
1.9
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Below adverse events were reported based on Safety Analysis Set (SAF), which included all participants who received any study drug in this study. The participants who dropped out after start of treatment before randomization were not allocated to a treatment arm, but were included in this SAF. | |||||
| Arm/Group Title | Early-start T&E Arm | Late-start T&E Arm | Treated, But Not Randomized | |||
| Arm/Group Description | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 to Week 104 participants randomized to Early-start T&E arm (Treat and Extend arm) received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | All participants during the initiation phase received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4, and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks) at Week 16. From Week 16 participants randomized to Late-start T&E arm received four 2Q8 injections. In Year 2 starting at Week 48, participants received treatment in individualized intervals of between 8 to16 weeks based on anatomical criteria. | Participants were treated during the initiation phase, received Aflibercept (Eylea, BAY86-5321) 3 doses at Weeks 0, 4 and 8 followed by one dose 2Q8 (2 mg administered every 8 weeks)at Week 16, but were not randomized to a treatment arm after the initiation phase. | |||
All Cause Mortality |
||||||
| Early-start T&E Arm | Late-start T&E Arm | Treated, But Not Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/135 (2.2%) | 4/136 (2.9%) | 0/16 (0%) | |||
Serious Adverse Events |
||||||
| Early-start T&E Arm | Late-start T&E Arm | Treated, But Not Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/135 (21.5%) | 35/136 (25.7%) | 3/16 (18.8%) | |||
| Cardiac disorders | ||||||
| Acute myocardial infarction | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 1/16 (6.3%) | 1 |
| Atrial fibrillation | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Atrial flutter | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Atrioventricular block | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Atrioventricular block second degree | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Cardiac arrest | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Cardiac failure congestive | 2/135 (1.5%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Cor pulmonale acute | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Coronary artery stenosis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Myocardial infarction | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Pericardial haemorrhage | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Ventricular tachycardia | 1/135 (0.7%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Congestive cardiomyopathy | 0/135 (0%) | 0 | 1/136 (0.7%) | 2 | 0/16 (0%) | 0 |
| Cardiac valve disease | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Eye disorders | ||||||
| Eye inflammation | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Retinal artery embolism | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Visual acuity reduced | 0/135 (0%) | 0 | 2/136 (1.5%) | 2 | 0/16 (0%) | 0 |
| Visual impairment | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Eyelid cyst | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 2/135 (1.5%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Constipation | 1/135 (0.7%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Duodenal ulcer perforation | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Gastritis | 1/135 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Gastrointestinal haemorrhage | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Haematochezia | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Ileus | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Inguinal hernia | 2/135 (1.5%) | 2 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Intestinal perforation | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Pancreatitis acute | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Small intestinal obstruction | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Large intestine polyp | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Noninfective sialoadenitis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| General disorders | ||||||
| Hernia | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Pyrexia | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Multiple organ dysfunction syndrome | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Acute hepatic failure | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Biliary colic | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Cholangitis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Cholecystitis | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Cholecystitis acute | 2/135 (1.5%) | 2 | 2/136 (1.5%) | 2 | 0/16 (0%) | 0 |
| Cholelithiasis | 1/135 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Infections and infestations | ||||||
| Bronchitis | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Cystitis | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Influenza | 2/135 (1.5%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Pneumonia | 3/135 (2.2%) | 4 | 5/136 (3.7%) | 5 | 0/16 (0%) | 0 |
| Pneumonia pseudomonal | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Sepsis | 1/135 (0.7%) | 1 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Enterococcal sepsis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Infective exacerbation of chronic obstructive airways disease | 3/135 (2.2%) | 4 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Adenovirus infection | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Concussion | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Facial bones fracture | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Hip fracture | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Rib fracture | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Splenic rupture | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Traumatic fracture | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Inflammation of wound | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Pelvic fracture | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Fluid overload | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Intervertebral disc protrusion | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Intervertebral disc disorder | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Fracture pain | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Adenocarcinoma of colon | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Basal cell carcinoma | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Bladder neoplasm | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Breast cancer | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Chronic myeloid leukaemia | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Lung neoplasm malignant | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Lung neoplasm | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Epithelioid mesothelioma | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Papillary renal cell carcinoma | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Nervous system disorders | ||||||
| Carotid artery stenosis | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Cerebral infarction | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Cerebrovascular accident | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 2/16 (12.5%) | 2 |
| Haemorrhagic stroke | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Hemiplegia | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Vertebrobasilar insufficiency | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Psychiatric disorders | ||||||
| Suicide attempt | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| End stage renal disease | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 1/135 (0.7%) | 2 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Cough | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Dyspnoea | 0/135 (0%) | 0 | 2/136 (1.5%) | 3 | 0/16 (0%) | 0 |
| Pleural effusion | 0/135 (0%) | 0 | 1/136 (0.7%) | 2 | 0/16 (0%) | 0 |
| Pulmonary embolism | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Surgical and medical procedures | ||||||
| Implantable defibrillator replacement | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Vascular disorders | ||||||
| Aortic aneurysm | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Aortic dissection | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Haematoma | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Hypovolaemic shock | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Intermittent claudication | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Deep vein thrombosis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Extremity necrosis | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Peripheral arterial occlusive disease | 1/135 (0.7%) | 1 | 0/136 (0%) | 0 | 0/16 (0%) | 0 |
| Peripheral artery stenosis | 0/135 (0%) | 0 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Early-start T&E Arm | Late-start T&E Arm | Treated, But Not Randomized | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 93/135 (68.9%) | 80/136 (58.8%) | 10/16 (62.5%) | |||
| Eye disorders | ||||||
| Blepharitis | 2/135 (1.5%) | 6 | 11/136 (8.1%) | 25 | 0/16 (0%) | 0 |
| Cataract | 9/135 (6.7%) | 14 | 8/136 (5.9%) | 13 | 0/16 (0%) | 0 |
| Cataract nuclear | 2/135 (1.5%) | 4 | 7/136 (5.1%) | 16 | 0/16 (0%) | 0 |
| Conjunctival haemorrhage | 20/135 (14.8%) | 26 | 18/136 (13.2%) | 20 | 0/16 (0%) | 0 |
| Corneal erosion | 5/135 (3.7%) | 6 | 2/136 (1.5%) | 3 | 1/16 (6.3%) | 1 |
| Dry eye | 6/135 (4.4%) | 11 | 11/136 (8.1%) | 18 | 0/16 (0%) | 0 |
| Erythema of eyelid | 0/135 (0%) | 0 | 0/136 (0%) | 0 | 1/16 (6.3%) | 2 |
| Macular degeneration | 6/135 (4.4%) | 6 | 5/136 (3.7%) | 5 | 1/16 (6.3%) | 1 |
| Punctate keratitis | 10/135 (7.4%) | 23 | 5/136 (3.7%) | 9 | 1/16 (6.3%) | 1 |
| Retinal haemorrhage | 4/135 (3%) | 4 | 6/136 (4.4%) | 7 | 2/16 (12.5%) | 2 |
| Swelling of eyelid | 0/135 (0%) | 0 | 0/136 (0%) | 0 | 1/16 (6.3%) | 2 |
| Visual acuity reduced | 21/135 (15.6%) | 24 | 17/136 (12.5%) | 19 | 1/16 (6.3%) | 1 |
| Visual impairment | 8/135 (5.9%) | 11 | 4/136 (2.9%) | 4 | 0/16 (0%) | 0 |
| Vitreous floaters | 8/135 (5.9%) | 8 | 4/136 (2.9%) | 5 | 0/16 (0%) | 0 |
| Vitreous adhesions | 1/135 (0.7%) | 1 | 2/136 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| Choroidal neovascularisation | 7/135 (5.2%) | 7 | 5/136 (3.7%) | 5 | 0/16 (0%) | 0 |
| Retinal pigment epithelial tear | 3/135 (2.2%) | 3 | 2/136 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| Neovascular age-related macular degeneration | 15/135 (11.1%) | 15 | 14/136 (10.3%) | 14 | 1/16 (6.3%) | 1 |
| Macular fibrosis | 2/135 (1.5%) | 2 | 6/136 (4.4%) | 6 | 1/16 (6.3%) | 1 |
| Infections and infestations | ||||||
| Gastroenteritis | 0/135 (0%) | 0 | 3/136 (2.2%) | 3 | 1/16 (6.3%) | 1 |
| Influenza | 11/135 (8.1%) | 12 | 12/136 (8.8%) | 13 | 0/16 (0%) | 0 |
| Nasopharyngitis | 18/135 (13.3%) | 21 | 17/136 (12.5%) | 22 | 0/16 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Foreign body in eye | 0/135 (0%) | 0 | 0/136 (0%) | 0 | 1/16 (6.3%) | 1 |
| Post procedural swelling | 0/135 (0%) | 0 | 0/136 (0%) | 0 | 1/16 (6.3%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dyslipidaemia | 0/135 (0%) | 0 | 0/136 (0%) | 0 | 1/16 (6.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 8/135 (5.9%) | 9 | 1/136 (0.7%) | 1 | 0/16 (0%) | 0 |
| Musculoskeletal pain | 1/135 (0.7%) | 1 | 2/136 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| Vascular disorders | ||||||
| Hypertension | 13/135 (9.6%) | 15 | 11/136 (8.1%) | 11 | 0/16 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Bayer |
| Phone | (+) 1-888-8422937 |
| clinical-trials-contact@bayer.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02581891
Other Study ID Numbers:
- 17508
- 2014-003132-39
First Posted:
Oct 21, 2015
Last Update Posted:
May 21, 2020
Last Verified:
May 1, 2020