Trial Outcomes & Findings for Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT) (NCT NCT01846273)

Last Updated: 2019-06-07

Results Overview

Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

321 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2019-06-07

Participant Flow

This study was conducted in the following jurisdictions: Japan (25 centers), Malaysia (2 centers), Singapore (4 centers), Hong Kong (2 centers), Taiwan (6 centers), Thailand (3 centers) and Korea (5 centers).

The enrollment number in the protocol section reflects the number of participants treated (321). The total number in the participant flow and baseline characteristics sections reflects the number of participants randomized (322).

Participant milestones

Participant milestones
Measure	Ranibizumab 0.5 mg + vPDT Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Overall Study STARTED	168	113	41
Overall Study Safety Analysis Set	172	135	14
Overall Study COMPLETED	146	87	41
Overall Study NOT COMPLETED	22	26	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab 0.5 mg + vPDT Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)
Overall Study Adverse Event	9	7
Overall Study Subject withdrew consent	5	8
Overall Study Lost to Follow-up	2	1
Overall Study Administrative problems	1	0
Overall Study Death	2	1
Overall Study Disease Progression	0	4
Overall Study Protocol Deviation	2	3
Overall Study Physician Decision	1	2

Baseline Characteristics

Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit	Total n=322 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 8.54 • n=5 Participants	67.8 years STANDARD_DEVIATION 9.19 • n=7 Participants	69.2 years STANDARD_DEVIATION 8.57 • n=5 Participants	68.1 years STANDARD_DEVIATION 8.76 • n=4 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	30 Participants n=7 Participants	8 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Male	109 Participants n=5 Participants	83 Participants n=7 Participants	33 Participants n=5 Participants	225 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=154 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye	8.3 Letters Standard Error 1.00	5.1 Letters Standard Error 1.06	—

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data

Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value "No." Polyp regression which may lead to disease stabilization and consequently better vision.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=154 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye	115 Participants	52 Participants	—

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: All patients with a BCVA value for both baseline and Month 24

Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye	9.7 Letters Standard Error 11.74	5.4 Letters Standard Error 12.75	6.1 Letters Standard Error 13.84

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: All participants with a BCVA value for both Baseline and Month 24.

BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye < 30 letters loss	99.3 Percentage of participants	97.7 Percentage of participants	100 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye ≥ 5 letters gain	74.0 Percentage of participants	57.5 Percentage of participants	51.2 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye ≥ 10 letters gain	51.4 Percentage of participants	36.8 Percentage of participants	43.9 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye ≥ 15 letters gain	30.8 Percentage of participants	24.1 Percentage of participants	24.4 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye < 5 letters loss	89.7 Percentage of participants	85.1 Percentage of participants	82.9 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye < 10 letters loss	94.5 Percentage of participants	92.0 Percentage of participants	90.2 Percentage of participants
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye < 15 letters loss	95.2 Percentage of participants	95.4 Percentage of participants	92.7 Percentage of participants

SECONDARY outcome

Timeframe: Month 3, Month 12, Month 24

Population: Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected.

Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3, Month 12, Month 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6, Month 24

Population: All patients who attended the specific visit

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 6 - Total	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 6 - Yes	71.3 Percentage of participants	30.4 Percentage of participants	22.0 Percentage of participants
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 6 - No	28.7 Percentage of participants	69.6 Percentage of participants	78.0 Percentage of participants
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 24 - Total	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 24 - Yes	56.6 Percentage of participants	26.7 Percentage of participants	47.5 Percentage of participants
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye Month 24 - No	43.4 Percentage of participants	73.3 Percentage of participants	52.5 Percentage of participants

SECONDARY outcome

Timeframe: Month 6, Month 12 and Month 24

Population: All patients who attended the specific visit

Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 12 - Total	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 6 - Total	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 6 - Yes	43 Percentage of participants	73.5 Percentage of participants	78 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 6 - No	55.1 Percentage of participants	26.5 Percentage of participants	22 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 6 - Can't grade	0.6 Percentage of participants	—	—
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 6 - Missing	1.3 Percentage of participants	—	—
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 12 - Yes	47.7 Percentage of participants	72.6 Percentage of participants	80.5 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 12 - No	51.6 Percentage of participants	27.4 Percentage of participants	19.5 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 12 - Missing	0 Percentage of participants	—	—
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 24 - Total	100 Percentage of participants	100 Percentage of participants	100 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 24 - Yes	56.8 Percentage of participants	65.1 Percentage of participants	56.1 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 24 - No	40.4 Percentage of participants	34.9 Percentage of participants	39 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 24 - Can't grade	0.7 Percentage of participants	—	2.4 Percentage of participants
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye Month 24 - Missing	2.1 Percentage of participants	—	2.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: All patients with a value at baseline and at Month 24

The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye Value at Baseline	401.6 Micrometers Standard Error 142.74	390 Micrometers Standard Error 124.12	412.5 Micrometers Standard Error 143.16
Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye Value at Month 24	248.8 Micrometers Standard Error 64.7	294.5 Micrometers Standard Error 108.61	273.8 Micrometers Standard Error 73.31
Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye Change from Baseline	-152.9 Micrometers Standard Error 129.74	-95.5 Micrometers Standard Error 148.36	-138.7 Micrometers Standard Error 124.94

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=149 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12	887 injections	1089 injections	—

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=149 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12	264 injections	345 injections	—

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24	1422 injections	1625 injections	225 injections

SECONDARY outcome

Timeframe: Baseline, Month 24

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24	389 injections	459 injections	81 injections

SECONDARY outcome

Timeframe: Month 3, Month 12

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=149 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12	378 injections	651 injections	—

SECONDARY outcome

Timeframe: Month 3, Month 24

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24	913 injections	1229 injections	183 injections

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 12, Month 24

Population: All patients with a value for both baseline and the specific post-baseline visit. The baseline value is the last available, non-missing, value collected prior to first study treatment in the study eye.

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=168 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=113 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=41 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 24 - Value at Baseline	76.4 Unit of scales Standard Deviation 13.72	76 Unit of scales Standard Deviation 15.48	80.3 Unit of scales Standard Deviation 12.77
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 24 - Value at Visit	81.9 Unit of scales Standard Deviation 14.12	80.8 Unit of scales Standard Deviation 13.37	83.2 Unit of scales Standard Deviation 12.12
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 3 - Value at Baseline	76.5 Unit of scales Standard Deviation 13.78	75.9 Unit of scales Standard Deviation 14.7	80.9 Unit of scales Standard Deviation 12.47
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 3 - Value at Visit	79.4 Unit of scales Standard Deviation 13.38	80.5 Unit of scales Standard Deviation 12.21	82.5 Unit of scales Standard Deviation 11.53
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 24 - Change from Baseline	5.5 Unit of scales Standard Deviation 13.23	4.8 Unit of scales Standard Deviation 14.92	2.8 Unit of scales Standard Deviation 15.69
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 3 - Change from Baseline	2.9 Unit of scales Standard Deviation 9.34	4.6 Unit of scales Standard Deviation 10.52	1.7 Unit of scales Standard Deviation 8.85
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 12 - Value at Baseline	76.4 Unit of scales Standard Deviation 13.6	75.8 Unit of scales Standard Deviation 15.2	80.3 Unit of scales Standard Deviation 12.77
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 12 - Value at Visit	82.8 Unit of scales Standard Deviation 13.55	81.2 Unit of scales Standard Deviation 13.54	83 Unit of scales Standard Deviation 11.18
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 Month 12 - Change from Baseline	6.4 Unit of scales Standard Deviation 12.31	5.4 Unit of scales Standard Deviation 13.54	2.7 Unit of scales Standard Deviation 13.76

SECONDARY outcome

Timeframe: Up to Month 24

Population: Safety Analysis Set

Reported categorically: Mild, Moderate, Severe

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Mild	55 Adverse Events	31 Adverse Events	7 Adverse Events
Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Moderate	7 Adverse Events	11 Adverse Events	1 Adverse Events
Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Severe	2 Adverse Events	7 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: Up to Month 24

Population: Safety Analysis Set

Reported categorically: Mild, Moderate, Severe

Outcome measures

Outcome measures
Measure	Ranibizumab 0.5 mg + vPDT n=172 Participants Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 Participants Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 Participants Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit
Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Severe	12 Adverse Events	6 Adverse Events	1 Adverse Events
Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Mild	65 Adverse Events	49 Adverse Events	6 Adverse Events
Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class Moderate	17 Adverse Events	17 Adverse Events	2 Adverse Events

Adverse Events

Ranibizumab 0.5 mg + vPDT

Serious events: 27 serious events

Other events: 80 other events

Deaths: 2 deaths

Ranibizumab 0.5 mg

Serious events: 23 serious events

Other events: 45 other events

Deaths: 1 deaths

Ranibizumab 0.5 mg + vPDT (Switched)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Ranibizumab 0.5 mg + vPDT n=172 participants at risk Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 participants at risk Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 participants at risk Ranibizumab 0.5 mg + vPDT (Switched)
Infections and infestations Pneumonia bacterial	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Wound infection	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Contusion	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Fall	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Heat exhaustion	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Laceration	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Blood and lymphatic system disorders Anaemia	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Cardiac disorders Acute myocardial infarction	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Cardiac disorders Cardiac valve disease	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Cardiac disorders Myocardial ischaemia	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Blindness unilateral (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Cataract (Fellow untreated eye)	1.2% 2/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Cataract (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Macular hole (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Ocular hypertension (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Polypoidal choroidal vasculopathy (Fellow untreated eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Retinal haemorrhage (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Vitreous haemorrhage (Fellow treated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Vitreous haemorrhage (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	2.2% 3/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Abdominal pain upper	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Colitis	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Ileus	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Inguinal hernia	1.2% 2/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Campylobacter colitis	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Diverticulitis	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Endophthalmitis (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Herpes zoster	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Lower respiratory tract infection	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Pneumonia	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	3.0% 4/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Limb injury	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Lower limb fracture	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Spinal compression fracture	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Tendon rupture	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Thermal burn	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Muscular weakness	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.

Other adverse events
Measure	Ranibizumab 0.5 mg + vPDT n=172 participants at risk Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT)	Ranibizumab 0.5 mg n=135 participants at risk Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT)	Ranibizumab 0.5 mg + vPDT (Switched) n=14 participants at risk Ranibizumab 0.5 mg + vPDT (Switched)
Ear and labyrinth disorders Cerumen impaction	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	14.3% 2/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Corneal disorder (Fellow untreated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Corneal disorder (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Dry eye (Fellow untreated eye)	5.2% 9/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	3.0% 4/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Dry eye (Study eye)	5.8% 10/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	3.0% 4/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Dyschromatopsia (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Eye irritation (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Lacrimation increased (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Ocular hyperaemia (Fellow untreated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Ocular hyperaemia (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Ocular hypertension (Study eye)	1.7% 3/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	2.2% 3/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Punctate keratitis (Fellow untreated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Punctate keratitis (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	2.2% 3/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Retinal haemorrhage (Study eye)	7.0% 12/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	3.0% 4/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Eye disorders Retinal vein occlusion (Fellow untreated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Constipation	2.9% 5/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Dental caries	1.7% 3/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Gastrointestinal disorders Gastritis erosive	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
General disorders Injection site pain (Study eye)	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
General disorders Mass	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
General disorders Non-cardiac chest pain	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Lower respiratory tract infection	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Nasopharyngitis	13.4% 23/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.4% 10/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	14.3% 2/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Periodontitis	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Pharyngitis	1.7% 3/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Respiratory tract infection	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Rhinitis	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.74% 1/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Tonsillitis	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Infections and infestations Upper respiratory tract infection	7.0% 12/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	1.5% 2/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	14.3% 2/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Foreign body in eye (Fellow untreated eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Foreign body in eye (Study eye)	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Head injury	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Laceration	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Injury, poisoning and procedural complications Wound	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Investigations Intraocular pressure increased	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Investigations Intraocular pressure increased (Study eye)	6.4% 11/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	2.2% 3/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	28.6% 4/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Metabolism and nutrition disorders Decreased appetite	0.58% 1/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Back pain	2.3% 4/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	0.00% 0/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	14.3% 2/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 2/172 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	3.0% 4/135 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.	7.1% 1/14 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. All safety evaluations were carried out on the Safety set. The Safety Set consisted of all patients who received at least one application of study drugs and had at least one post-baseline safety assessment. The statement that a patient had no AEs also constituted a safety assessment. Within the safety set, patients were analyzed as treated.