Trial Outcomes & Findings for VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV) (NCT NCT01249664)

NCT ID: NCT01249664

Last Updated: 2014-05-05

Results Overview

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 122 participants
• Primary outcome timeframe: Baseline, Week 24
• Results posted on: 2014-05-05

Participant Flow

The study was conducted at 20 study centers in 5 countries. Recruitment period: 17 Dec 2010 - 28 Feb 2013.

A total of 173 participants were screened.

Participant milestones

Measure	Aflibercept Injection First, Then Aflibercept or Sham Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Overall Study STARTED	91	31
Overall Study Participants Received Treatment	91	31
Overall Study Fulfilled Requirements of FAS Population	90	31
Overall Study Completed 24 Weeks Treatment	83	25
Overall Study Completed 48 Weeks Treatment	78	24
Overall Study COMPLETED	85	31
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Measure	Aflibercept Injection First, Then Aflibercept or Sham Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Overall Study Withdrawal by Subject	5	0
Overall Study Adverse Event	1	0

Baseline Characteristics

VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

Baseline characteristics by cohort

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Total n=121 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 13.7 • n=5 Participants	57.5 Years STANDARD_DEVIATION 12.1 • n=7 Participants	58.2 Years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	27 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	4 Participants n=7 Participants	29 Participants n=5 Participants
Baseline Best Corrected Visual Acuity (BCVA) letter scores	56.4 Letters correctly read STANDARD_DEVIATION 9.8 • n=5 Participants	56.6 Letters correctly read STANDARD_DEVIATION 8.9 • n=7 Participants	56.5 Letters correctly read STANDARD_DEVIATION 9.5 • n=5 Participants
Baseline Central Retinal Thickness by Optical Coherence Tomography (OCT)	349.7 µm STANDARD_DEVIATION 91.3 • n=5 Participants	354.2 µm STANDARD_DEVIATION 107.2 • n=7 Participants	350.9 µm STANDARD_DEVIATION 95.2 • n=5 Participants
Baseline intraocular pressure	15.2 mm Hg STANDARD_DEVIATION 2.7 • n=5 Participants	15.8 mm Hg STANDARD_DEVIATION 2.8 • n=7 Participants	15.4 mm Hg STANDARD_DEVIATION 2.7 • n=5 Participants
Number of participants by category of time since mCNV diagnosis >= 2 months	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Number of participants by category of time since mCNV diagnosis < 2 months	73 Participants n=5 Participants	24 Participants n=7 Participants	97 Participants n=5 Participants
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score	70.47 scores on a scale STANDARD_DEVIATION 13.48 • n=5 Participants	72.73 scores on a scale STANDARD_DEVIATION 15.29 • n=7 Participants	71.04 scores on a scale STANDARD_DEVIATION 13.94 • n=5 Participants
European questionnaire 5 dimensions (EQ-5D) total score	0.88 score on a scale STANDARD_DEVIATION 0.18 • n=5 Participants	0.88 score on a scale STANDARD_DEVIATION 0.15 • n=7 Participants	0.88 score on a scale STANDARD_DEVIATION 0.18 • n=5 Participants
Race Asian	90 Participants n=5 Participants	31 Participants n=7 Participants	121 Participants n=5 Participants
Race White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Choroidal neovascularization (CNV) size	0.4086 disc area STANDARD_DEVIATION 0.5028 • n=5 Participants	0.3334 disc area STANDARD_DEVIATION 0.3413 • n=7 Participants	0.3894 disc area STANDARD_DEVIATION 0.4666 • n=5 Participants
Baseline area of leakage	0.7005 disc area STANDARD_DEVIATION 0.6830 • n=5 Participants	0.6867 disc area STANDARD_DEVIATION 0.5563 • n=7 Participants	0.6970 disc area STANDARD_DEVIATION 0.6507 • n=5 Participants
Duration of disease	145.6 days STANDARD_DEVIATION 437.4 • n=5 Participants	177.1 days STANDARD_DEVIATION 512.0 • n=7 Participants	153.7 days STANDARD_DEVIATION 455.6 • n=5 Participants
Baseline axial length	28.791 millimeter (mm) STANDARD_DEVIATION 1.524 • n=5 Participants	28.610 millimeter (mm) STANDARD_DEVIATION 1.696 • n=7 Participants	28.745 millimeter (mm) STANDARD_DEVIATION 1.564 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)	12.1 Letters correctly read Standard Deviation 8.3	-2.0 Letters correctly read Standard Deviation 9.7

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach	38.9 Percentage of participants	9.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=84 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=25 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases	12.0 Letters correctly read Standard Deviation 8.4	-0.8 Letters correctly read Standard Deviation 9.3

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF	63.3 Percentage of participants	12.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF	83.3 Percentage of participants	19.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF	50.0 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF	68.9 Percentage of participants	41.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF	87.8 Percentage of participants	45.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF	0 Percentage of participants	6.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF	0 Percentage of participants	25.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF	3.3 Percentage of participants	35.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF	1.1 Percentage of participants	6.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF	1.1 Percentage of participants	22.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF	3.3 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

A negative number indicates improvement (reduced thickness).

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF	-79.1 microns Standard Deviation 83.7	-4.2 microns Standard Deviation 127.4

SECONDARY outcome

Timeframe: Baseline, Week 48

A negative number indicates improvement (reduced thickness).

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF	-83.1 microns Standard Deviation 85.5	-56.7 microns Standard Deviation 119.0

SECONDARY outcome

Timeframe: Baseline, Week 24

CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF	-0.2233 Disc areas Standard Deviation 0.3195	0.3007 Disc areas Standard Deviation 0.4383

SECONDARY outcome

Timeframe: Baseline, Week 48

CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF	-0.1995 Disc areas Standard Deviation 0.4281	-0.0111 Disc areas Standard Deviation 0.4031

SECONDARY outcome

Timeframe: Baseline, Week 24

EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF	0.0187 Scores on a scale Standard Deviation 0.1749	0.0341 Scores on a scale Standard Deviation 0.1723

SECONDARY outcome

Timeframe: Baseline, Week 24

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.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF	3.14 Scores on a scale Standard Deviation 10.21	-2.58 Scores on a scale Standard Deviation 10.07

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks	6.7 Percentage of participants	19.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

A negative change from baseline indicates improvement, ie, less leakage.

Outcome measures

Measure	Aflibercept Injection First, Then Aflibercept or Sham n=90 Participants Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Sham Treatment First, Then Aflibercept Injection or Sham n=31 Participants Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Mean Change in Area of Leakage From Baseline at Week 24 - LOCF	-0.4743 Disc areas Standard Deviation 0.4839	0.2094 Disc areas Standard Deviation 0.5088

Adverse Events

Aflibercept Injection (Until Week 20)

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Sham Treatment (Until Week 20)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Aflibercept Injection (Until Week 44)

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Sham Treatment Then Aflibercept Injection (Until Week 44)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aflibercept Injection (Until Week 20) n=91 participants at risk Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.	Sham Treatment (Until Week 20) n=31 participants at risk Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.	Aflibercept Injection (Until Week 44) n=91 participants at risk Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.	Sham Treatment Then Aflibercept Injection (Until Week 44) n=31 participants at risk Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Choroidal neovascularisation	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Macular hole	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	2.2% 2/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Infections and infestations Pneumonia moraxella	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Nervous system disorders Cerebral haemorrhage	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Psychiatric disorders Depression	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.

Other adverse events

Measure	Aflibercept Injection (Until Week 20) n=91 participants at risk Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.	Sham Treatment (Until Week 20) n=31 participants at risk Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.	Aflibercept Injection (Until Week 44) n=91 participants at risk Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.	Sham Treatment Then Aflibercept Injection (Until Week 44) n=31 participants at risk Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
Eye disorders Conjunctival haemorrhage	7.7% 7/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	7.7% 7/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Dry eye	6.6% 6/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	1.1% 1/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Eye pain	6.6% 6/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	2.2% 2/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Posterior capsule opacification	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	9.7% 3/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Eye disorders Punctate keratitis	4.4% 4/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	9.7% 3/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	5.5% 5/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	9.7% 3/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Gastrointestinal disorders Nausea	5.5% 5/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.3% 3/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Infections and infestations Herpes zoster	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	6.5% 2/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Infections and infestations Nasopharyngitis	9.9% 9/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	6.5% 2/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	9.9% 9/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	6.5% 2/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Nervous system disorders Headache	6.6% 6/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	3.2% 1/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/91 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.	0.00% 0/31 • From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER