Trial Outcomes & Findings for Nepafenac Once Daily for Macular Edema - Study 1 (NCT NCT01853072)

Last Updated: 2016-08-03

Results Overview

BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

881 participants

Primary outcome timeframe

Baseline to Day 14, and maintained through Day 90

Results posted on

2016-08-03

Participant Flow

Participants were recruited from 66 investigational centers located in the U.S., Latin America, and the Caribbean.

Of the 881 participants enrolled, 253 were exited as screen failures and 13 were discontinued prior to randomization. This reporting group includes all randomized participants (615).

Participant milestones

Participant milestones
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.3%	Vehicle Nepafenac Ophthalmic Suspension Vehicle
Overall Study STARTED	308	307
Overall Study Randomized	308	307
Overall Study Treated (Safety Analysis Set)	301	302
Overall Study Full Analysis Set	298	300
Overall Study COMPLETED	296	286
Overall Study NOT COMPLETED	12	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.3%	Vehicle Nepafenac Ophthalmic Suspension Vehicle
Overall Study Adverse event prior to treatment	0	1
Overall Study Adverse Event	0	3
Overall Study Death	1	4
Overall Study Lost to Follow-up	0	3
Overall Study Non-compliance with study drug	0	1
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	1	2
Overall Study Reason not specified	9	6

Baseline Characteristics

Nepafenac Once Daily for Macular Edema - Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle	Total n=598 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 8.5 • n=5 Participants	66.8 years STANDARD_DEVIATION 8.3 • n=7 Participants	66.8 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	158 Participants n=5 Participants	166 Participants n=7 Participants	324 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	134 Participants n=7 Participants	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 14, and maintained through Day 90

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90	61.7 Percentage of participants	43.0 Percentage of participants

PRIMARY outcome

Timeframe: Day 0 to Day 90

Population: Full analysis set

Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)	2.3 Percentage of participants	17.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 90

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90	77.2 Percentage of participants	67.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 60

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60	76.2 Percentage of participants	64.7 Percentage of participants

SECONDARY outcome

Timeframe: Day 7 up to any visit through Day 90

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]	15.4 percentage of participants	27.3 percentage of participants

SECONDARY outcome

Timeframe: Day 7 up to any visit through Day 90

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=298 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=300 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit	9.1 percentage of participants	15.3 percentage of participants

Adverse Events

Pretreatment

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Nepafenac

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Posttreatment

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Unit Head, Cornea and Inflammation

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Pretreatment n=881 participants at risk All participants who consented to participate in the study prior to the initiation of study treatment	Nepafenac n=301 participants at risk All participants treated with Nepafenac during the course of study treatment	Vehicle n=302 participants at risk All participants treated with NepafenacVehicle during the course of study treatment	Posttreatment n=603 participants at risk All participants after cessation of study treatment up to study exit
Blood and lymphatic system disorders Anaemia	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Acute coronary syndrome	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Angina pectoris	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Atrial fibrillation	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Bradycardia	0.23% 2/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Cardiac arrest	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Cardiac failure congestive	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.99% 3/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Myocardial infarction	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Gastrointestinal disorders Rectal haemorrhage	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
General disorders Non-cardiac chest pain	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
General disorders Oedema peripheral	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Bronchitis	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Candidiasis	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Cellulitis	0.23% 2/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Diverticulitis	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Pericolic abscess	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Peritonitis	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Pneumonia	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 2/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Retroperitoneal abscess	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Sepsis	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.99% 3/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Urinary tract infection	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Viral infection	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Wound infection	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Eye injury	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Laceration	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Multiple fractures	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Investigations Arteriogram	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Metabolism and nutrition disorders Dehydration	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Nervous system disorders Hepatic encephalopathy	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Nervous system disorders Transient ischaemic attack	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Nervous system disorders VIth nerve paralysis	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Psychiatric disorders Confusional state	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Renal and urinary disorders Acute prerenal failure	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Renal and urinary disorders Renal failure acute	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Renal and urinary disorders Renal failure chronic	0.00% 0/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.33% 1/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.11% 1/881 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/301 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/302 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/603 • Reporting of adverse events (AEs) began once informed consent was obtained from the subject and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular AEs are presented for both study eye and non-study eye combined. An AE was defined as any untoward medical occurrence in a subject after signing the informed consent document. AEs were reported as pretreatment, treatment-emergent, and posttreatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.