Trial Outcomes & Findings for Nepafenac Once Daily for Macular Edema - Study 2 (NCT NCT01872611)

Last Updated: 2016-08-02

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

819 participants

Primary outcome timeframe

Baseline to Day 14, and maintained through Day 90

Results posted on

2016-08-02

Participant Flow

Participants were recruited from 73 investigational centers located in the U.S., Europe, the Middle East, Africa, Latin America, the Caribbean, and the Asia Pacific region.

Of the 819 participants enrolled, 191 were exited as screen failures and 23 were discontinued prior to randomization. This reporting group includes all randomized participants (605).

Participant milestones

Participant milestones
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.3%	Vehicle Nepafenac Ophthalmic Suspension Vehicle
Overall Study STARTED	301	304
Overall Study Randomized	301	304
Overall Study Treated (Safety Analysis Set)	293	295
Overall Study Full Analysis Set	289	293
Overall Study COMPLETED	277	292
Overall Study NOT COMPLETED	24	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Nepafenac Nepafenac Ophthalmic Suspension, 0.3%	Vehicle Nepafenac Ophthalmic Suspension Vehicle
Overall Study Adverse Event	3	1
Overall Study Adverse Event, prior to treatment	0	1
Overall Study Death	0	1
Overall Study Death, prior to treatment	0	1
Overall Study Lost to Follow-up	8	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	6	1
Overall Study Reason not provided	6	6

Baseline Characteristics

Nepafenac Once Daily for Macular Edema - Study 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nepafenac n=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle	Total n=582 Participants Total of all reporting groups
Age, Continuous	67.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	68.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	67.9 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	149 Participants n=5 Participants	149 Participants n=7 Participants	298 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants	144 Participants n=7 Participants	284 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=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 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	48.8 Percentage of participants	50.5 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=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)	5.9 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 90

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90	65.4 Percentage of participants	65.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 60

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Nepafenac n=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60	68.9 Percentage of participants	62.1 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=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit	18.7 percentage of participants	16.7 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=289 Participants Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=293 Participants Nepafenac Ophthalmic Suspension Vehicle
Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit	10.7 percentage of participants	8.9 percentage of participants

Adverse Events

Pretreatment

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Nepafenac

Serious events: 14 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: 4 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=819 participants at risk All participants who consented to participate in the study prior to the initiation of study treatment	Nepafenac n=293 participants at risk Nepafenac Ophthalmic Suspension, 0.3%	Vehicle n=295 participants at risk Nepafenac Ophthalmic Suspension Vehicle	Posttreatment n=588 participants at risk All participants after cessation of study treatment up to study exit
Blood and lymphatic system disorders Anaemia	0.12% 1/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Angina pectoris	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Atrial fibrillation	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Atrial flutter	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Cardiac failure	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Cardiac failure congestive	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Cardiac disorders Coronary artery occlusion	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Diabetic retinal oedema	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Optic ischaemic neuropathy	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Eye disorders Posterior capsule rupture	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
General disorders Chest pain	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
General disorders Device dislocation	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Immune system disorders Anaphylactic shock	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Appendicitis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Cellulitis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Herpes zoster	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Pyelonephritis acute	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Infections and infestations Urinary tract infection	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.68% 2/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.17% 1/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Nervous system disorders Cerebrovascular accident	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.68% 2/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Nervous system disorders Hepatic encephalopathy	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.12% 1/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Surgical and medical procedures Arteriovenous fistula operation	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Surgical and medical procedures Cardiac operation	0.12% 1/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Surgical and medical procedures Cataract operation	0.12% 1/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Surgical and medical procedures Intra-ocular injection	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Surgical and medical procedures Skin graft	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Vascular disorders Hypertension	0.12% 1/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Vascular disorders Hypertensive crisis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Vascular disorders Peripheral artery stenosis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.
Vascular disorders Thrombosis	0.00% 0/819 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.34% 1/293 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/295 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.	0.00% 0/588 • Reporting of adverse events (AEs) began once informed consent was obtained and continued through Day 90 (or Day 120, if unresolved macular edema present at Day 90). Ocular adverse events are presented for both study eye and nonstudy eye combined. An AE was defined as any untoward medical occurrence in a participant after signing the informed consent and did not necessarily have to have a causal relationship with the study treatment. AEs were reported as pretreatment, treatment-emergent, and posttreatment. AEs were obtained through solicited and spontaneous comments from the participants.