CEDAR: A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02462928
• Collaborator: (none)
• Enrollment: 939
• Locations: 151
• Arms: 3
• Actual Duration (Months): 47.8
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: Abicipar Pegol; Drug: Ranibizumab; Other: Sham Procedure	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 939 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (CEDAR Study)
• Actual Study Start Date: Jun 25, 2015
• Actual Primary Completion Date: Apr 18, 2018
• Actual Study Completion Date: Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abicipar Pegol 2 mg (2Q8) Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Drug: Abicipar Pegol; Abicipar pegol intravitreal injection.; Other Names: AGN-150998 ; Other: Sham Procedure; Sham injection.
Experimental: Abicipar Pegol 2 mg (2Q12) Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Drug: Abicipar Pegol; Abicipar pegol intravitreal injection.; Other Names: AGN-150998 ; Other: Sham Procedure; Sham injection.
Active Comparator: Ranibizumab 0.5 mg (rQ4) Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.	Drug: Ranibizumab; Ranibizumab intravitreal injection.; Other Names: Lucentis®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Stable Vision at Week 52 [Baseline to Week 52]

   Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.

Secondary Outcome Measures

1. Mean Change From Baseline in BCVA in the Study Eye at Week 52 [Baseline to Week 52]

   BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.

2. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 [Baseline to Week 52]

   CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.

3. Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 [Baseline to Week 52]

   BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.

4. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52 [Baseline to Week 52]

   NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of age-related macular degeneration in at least 1 eye

• Best corrected visual acuity of 20/40 to 20/320 in the study eye

• Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

• History of vitrectomy, macular surgery, or glaucoma surgery in the study eye

• Cataract or refractive surgery in the study eye within the last 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Research Institute, LLC	Phoenix	Arizona	United States	85014
2	Associated Retina Consultants, Ltd.	Phoenix	Arizona	United States	85020
3	Arizona Retina and Vitreous Consultants	Phoenix	Arizona	United States	85021
4	Retina Associates Southwest, P.C.	Tucson	Arizona	United States	85710
5	The Retina Partners	Encino	California	United States	91436
6	Retina Consultants of Orange County	Fullerton	California	United States	92835
7	Mark B. Kislinger MD Inc.	Glendora	California	United States	91741
8	Atlantis Retina Institute (Atlantis Eyecare)	Huntington Beach	California	United States	92647
9	Loma Linda University Medical Center	Loma Linda	California	United States	92354
10	Northern California Retina Vitreous Associates Medical Group, INC.	Mountain View	California	United States	94040
11	Retina Institute of California	Palm Desert	California	United States	92260
12	Doheny Vision Research	Pasadena	California	United States	91105
13	Orange County Retina Medical Group	Santa Ana	California	United States	92705
14	California Retina Consultants	Santa Barbara	California	United States	93103
15	Retina Eye Specialists	South Pasadena	California	United States	91030
16	Colorado Retina Associates	Golden	Colorado	United States	80401
17	Retina Health Center	Fort Myers	Florida	United States	33907
18	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
19	Florida Retina Consultants	Lakeland	Florida	United States	33805
20	Ocala Eye PA	Ocala	Florida	United States	34474
21	Magruder Eye Institute	Orlando	Florida	United States	32803
22	Retina Care Specialists	Palm Beach Gardens	Florida	United States	33410
23	Retina Specialty Institute	Pensacola	Florida	United States	32503
24	Retina Vitreous Associates of Florida - Saint Petersburg	Saint Petersburg	Florida	United States	33711
25	USF Eye Institute	Tampa	Florida	United States	33612
26	Georgia Retina, P.C.	Marietta	Georgia	United States	30060
27	Marietta Eye Clinic - Main Office	Marietta	Georgia	United States	30060
28	Thomas Eye Group, PC	Sandy Springs	Georgia	United States	30328
29	Retina Consultants of Hawaii, Inc.	'Aiea	Hawaii	United States	96701
30	Gailey Eye Clinic	Bloomington	Illinois	United States	61704
31	Carle at the Fields	Champaign	Illinois	United States	61822
32	University Retina and Macula Associates, PC	Lemont	Illinois	United States	60439
33	Raj K. Maturi, MD, PC	Indianapolis	Indiana	United States	46290
34	John Kenyon American Eye Institute	New Albany	Indiana	United States	47150
35	Ochsner Health Center	New Orleans	Louisiana	United States	70121
36	Retina Specialists	Baltimore	Maryland	United States	21204
37	The Bert M Glaser National Retina Institute	Towson	Maryland	United States	21204
38	Lahey Medical Center	Peabody	Massachusetts	United States	01960
39	Kellog Eye Center - University of Michigan Health System	Ann Arbor	Michigan	United States	48105
40	University of Minnesota	Minneapolis	Minnesota	United States	55455
41	Sierra Eye Associates	Reno	Nevada	United States	89502
42	Retina Associates of New Jersey	Teaneck	New Jersey	United States	07666
43	Capital Region Retina, PLLC	Albany	New York	United States	12206
44	SUNY Downstate Medical Center	Brooklyn	New York	United States	11201
45	Long Island Vitreoretinal Consultants	Great Neck	New York	United States	11021
46	Ophthalmic Consultants of Long Island	Oceanside	New York	United States	11572
47	Retina Associates of Western New York	Rochester	New York	United States	14620
48	Island Retina	Shirley	New York	United States	11967
49	Carolina Eye Associates	Southern Pines	North Carolina	United States	28387
50	Wake Forest Baptist Health Eye Center	Winston-Salem	North Carolina	United States	27157
51	Apex Eye Clinical Research	Fairfield	Ohio	United States	45014
52	Lancaster Retina Specialists	Lancaster	Pennsylvania	United States	17601
53	Mid Atlantic Retina	Philadelphia	Pennsylvania	United States	19107
54	Associates in Ophthalmology, Ltd.	West Mifflin	Pennsylvania	United States	15122
55	Retina Consultants of Carolina	Greenville	South Carolina	United States	29605
56	Charleston Neuroscience Institute	Ladson	South Carolina	United States	29456
57	Retina Research Institute of Texas	Abilene	Texas	United States	79606
58	Texas Retina Associates	Arlington	Texas	United States	76012
59	Texan Eye	Austin	Texas	United States	78731
60	TX Retina Associates	Dallas	Texas	United States	75231
61	Houston Eye Associates (HEA) - Gramercy Location	Houston	Texas	United States	77025
62	Retina and Vitreous of Texas	Houston	Texas	United States	77025
63	Retinal Consultants of Houston	Houston	Texas	United States	77030
64	San Antonio Eye Center	San Antonio	Texas	United States	78215
65	Medical Center Ophthalmology Associates	San Antonio	Texas	United States	78240
66	Retinal Consultants of San Antonio	San Antonio	Texas	United States	78240
67	Retina Consultants of Houston	The Woodlands	Texas	United States	77384
68	Retina Associates of Utah	Salt Lake City	Utah	United States	84107
69	University of Virginia - Department of Ophthalmology	Charlottesville	Virginia	United States	22908
70	Piedmont Eye Center, Inc.	Lynchburg	Virginia	United States	24502
71	Retina Institute of Virginia	Richmond	Virginia	United States	23235
72	Clinica Privada Kaufer Cataract Center	Martinez	Buenos Aires	Argentina	B1640BNT
73	Hospital Universitario Austral	Pilar	Buenos Aires	Argentina	B1629ODT
74	Centro Oftalmologico Rosario SRL	Rosario	Santa Fe	Argentina	S2000ANJ
75	Grupo Laser Vision	Rosario	Santa Fe	Argentina	S2000AZH
76	Organizacion Medica de Investigacion	Buenos Aires		Argentina	C1015ABO
77	Instituto Oftalmologico de Buenos Aires - Oftalmos	Buenos Aires		Argentina	C1120AAN
78	Centro Privado de Ojos Romagosa	Cordoba		Argentina	X5000AAJ
79	Instituto Oftalmologico de Cordoba	Cordoba		Argentina	X5000IIT
80	Oftar Centro Privado de Oftalmologia	Mendoza		Argentina	M5500GGK
81	Medical University Graz	Graz		Austria	8036
82	Medizinische Universitat Innsbruck, Univ.	Innsbruck		Austria	6020
83	Kepler Universitatsklinikum GmBH	Linz		Austria	4020
84	Konventhospital Barmherzige Brueder Linz	Linz		Austria	4021
85	KYDOFT	Santiago	Las Condes	Chile	7560994
86	Instituto Oftalmologica Profesor Arentsen	Santiago	Región Metropolitana	Chile	7510168
87	Centro Medico Imbanaco	Cali	Valle Del Cauca	Colombia	760042
88	Fundacion Oftalmologica Nacional - FUNDONAL	Bogota		Colombia
89	Fakultni nemocnice Brno	Brno		Czechia	62500
90	Fakultni nemocnice Olomouc	Olomouc		Czechia	77900
91	Fakultni nemocnice Kralovske Vinohrady Oftalmologicka klinika	Praha		Czechia	100 34
92	Vseobecna fakultni nemocnice v Praze Ocni Klinika	Praha		Czechia	128 00
93	Hopital Pellegrin	Bordeaux		France	33076
94	Centre Hospitalier Intercommunal de Creteil	Creteil		France	94010
95	Hopital de la Croix Rousse, Service d'Opthalmologie	Lyon cedex 04		France	69417
96	CHU de Nantes	Nantes Cedex 1		France	44093
97	Centre Ophtalmologique d'Imagerie et de Laser	Paris		France	75015
98	Centre Ophtalmologique Saint Exupery	Saint Cyr sur Loire		France	37540
99	Dardenne Eye Hospital	Bad Godesberg		Germany	53177
100	Klinikum Dresden Friedrichstadt	Dresden		Germany	01067
101	Internationale Innovative Ophthalmochirurgie Breyer & Kaymak & Klabe Augenchirurgie	Dusseldorf		Germany	40212
102	Eye Center, University of Freiburg	Freiburg		Germany	79106
103	Universitats-augenklinik Gottingen	Gottingen		Germany	37075
104	Stadtisches Klinikum	Karlsruhe		Germany	76133
105	Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde	Leipzig		Germany	04103
106	Universitätsklinikum Giessen und Marburg GmbH	Marburg		Germany	35043
107	Augenklinik im Dietrich-Bonhoeffer - Klinikum Neubrandenburg	Neubrandenburg		Germany	17036
108	Clinic and policlinic of ophthalmology, University of Regensburg	Regensburg		Germany	93053
109	The University of Hong Kong	Aberdeen		Hong Kong
110	The Chinese University of Hong Kong Hongkong eye hospital	Kowloon		Hong Kong
111	Bnai Zion Medical Center (BZMC) Technion-Israel Institute of Technology	Haifa		Israel	31048
112	Rambam Health Care Campus	Haifa		Israel	31096
113	Carmel Medical Center Ophthalmology Clinic	Haifa		Israel	34362
114	Edith Wolfson Medical Center	Holon		Israel	58100
115	Meir Medical Center	Kfar-Saba		Israel	44281
116	Rabin Medical Center Beilinson Hospital	Petach Tikva		Israel	49100
117	Kaplan Medical Center	Rehovot		Israel	76100
118	TASMC (The Tel-Aviv Sourasky Medical Centre)	Tel Aviv		Israel	64239
119	Chaim Sheba Medical Center Goldschleger Eye Clinic Sheba Medical Center	Tel Hashomer		Israel	52621
120	Shamir Medical Centre	Zerifin		Israel	70300
121	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707
122	The Catholic Univ. Of Seoul St. Mary's Hospital	Seocho	Seoul	Korea, Republic of	137-701
123	Asan Medical Center	Seoul		Korea, Republic of	05505
124	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
125	Yonsei University Health System Serverance Hospital	Seoul		Korea, Republic of	120-752
126	Pauls Stradins Clinical University Hospital Opthalmology Clinic	Riga	LV	Latvia	LV-1002
127	Auckland Eye	Remuera	Auckland	New Zealand	1051
128	University of Auckland	Auckland		New Zealand	1123
129	Cebu Doctors University Hospital	Cebu City	Metro Manila	Philippines	6000
130	Asian Eye Institute	Makati City	Metro Manila	Philippines	1200
131	Pacific Eyecare and Laser Institute	Makati City	Metro Manila	Philippines	1209
132	The Medical City	Pasig City	Metro Manila	Philippines	1600
133	St. Luke's Medical Center	Quezon City	Metro Manila	Philippines	1102
134	National University Hospital	Singapore		Singapore	119228
135	Singapore National Eye Centre- Singapore Eye Research Institute (SNECSERI)	Singapore		Singapore	168751
136	Centro de Oftalmologia Barraquer	Barcelona		Spain	08021
137	Institut Clinic d'Oftalmologia Hospital Clinic de Barcelona	Barcelona		Spain	08028
138	Instituto de Microcirugía Ocular DOS, S.L.U Area de Consultas	Barcelona		Spain	08035
139	Hospital Universitario de Bellvitge	Barcelona		Spain	08907
140	Valles Oftalmologia Research Hospital	Barcelona		Spain	08915
141	Instituto Clínico Quirúrgico de Oftalmología (ICQO)	Bilbao		Spain	48006
142	Hospital Clinico San Carlos	Madrid		Spain	28040
143	Clinica Universidad de Navarra Servicio de Oftalmologia	Pamplona		Spain	31008
144	Hospital General de Valencia Unidad de Investigacion Clinica	Valencia		Spain	46014
145	Hospital Universitari i Politecnic La Fe	Valencia		Spain	46026
146	Hospital Clinico Universitario	Valladolid		Spain	47005
147	Hospital Clínico Universitario Lozano Blesa. Unidad de Retina Médica y Quirúrgica	Zaragoza		Spain	50009
148	Hospital Miguel Servet	Zaragoza		Spain	50009
149	Universitatsklinik fur Augenheilkunde, Inselspital	Bern		Switzerland	3010
150	VISTA Klinik Binningen	Binningen		Switzerland	4102
151	Stiftung für wissenschaftliche Forschung am Stadtspital Triemli	Zurich		Switzerland	8063

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Joanne Li, Allergan

Study Documents (Full-Text)

• Statistical Analysis Plan - May 16, 2018
• Study Protocol - Apr 10, 2018

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02462928
• Other Study ID Numbers: 150998-005; 2014-004579-22; CEDAR
• First Posted: Jun 4, 2015
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab

Study Results

Participant Flow

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Period Title: Overall Study
STARTED	314	313	312
COMPLETED	224	221	255
NOT COMPLETED	90	92	57

Baseline Characteristics

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)	Total
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.	Total of all reporting groups
Overall Participants	314	313	312	939
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.5 (8.4)	76.9 (8.0)	77.1 (8.4)	76.5 (8.3)
Sex: Female, Male (Count of Participants)
Female	162 51.6%	183 58.5%	169 54.2%	514 54.7%
Male	152 48.4%	130 41.5%	143 45.8%	425 45.3%
Race/Ethnicity, Customized (Count of Participants)
White	249 79.3%	248 79.2%	243 77.9%	740 78.8%
Black	2 0.6%	1 0.3%	1 0.3%	4 0.4%
Asian	49 15.6%	44 14.1%	45 14.4%	138 14.7%
Hispanic	12 3.8%	12 3.8%	11 3.5%	35 3.7%
Not Reported	2 0.6%	8 2.6%	12 3.8%	22 2.3%
Best-corrected Visual Acuity (BCVA) Per Per-protocol Population (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	56.7 (13.3)	56.3 (13.1)	56.5 (12.6)	56.5 (13.0)
BCVA Per ITT Population (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	56.4 (13.4)	56.5 (12.9)	56.5 (12.5)	56.5 (12.9)
Central Retinal Thickness (CRT) (microns) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [microns]	384.7 (142.7)	378.4 (119.1)	378.2 (120.5)	380.4 (127.8)
National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) (score on a scale) [Mean (Full Range) ]
Mean (Full Range) [score on a scale]	78.7	77.3	77.1	77.7

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Stable Vision at Week 52
Description	Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

The per-protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately.

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Measure Participants	265	262	290
Number [percentage of participants]	91.7 29.2%	91.2 29.1%	95.5 30.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95.1%; -8.2 to 0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as stratification factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95.1%; -8.7 to 0.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as stratification factor.

2. Secondary Outcome

Title	Mean Change From Baseline in BCVA in the Study Eye at Week 52
Description	BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

The PP population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. Number of participants analyzed was based on observed data; missing data were not imputed.

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Measure Participants	241	239	272
Mean (Standard Deviation) [letters]	6.7 (12.9)	5.6 (13.3)	8.5 (13.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is > - 5.0 letters.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares (LS) Mean Difference
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95.1%; -4.7 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	MMRM included treatment, region, BL BCVA, BL CRT ≤400 or >400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is > - 5.0 letters.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.7
	Confidence Interval	(2-Sided) 95.1%; -6.0 to -1.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	MMRM included treatment, region, BL BCVA, BL CRT ≤400 or >400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.

3. Secondary Outcome

Title	Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52
Description	CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Measure Participants	242	235	269
Mean (Standard Deviation) [microns]	-141.5 (136.4)	-150.1 (127.4)	-141.3 (122.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	8.6
	Confidence Interval	(2-Sided) 95.1%; -3.8 to 20.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.3
	Estimation Comments	MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95.1%; -10.1 to 14.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.3
	Estimation Comments	MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.

4. Secondary Outcome

Title	Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52
Description	BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants.

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Measure Participants	314	313	312
Number [percentage of participants]	22.6 7.2%	19.2 6.1%	27.2 8.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-4.7
	Confidence Interval	(2-Sided) 95.1%; -11.5 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as the stratification factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-8.2
	Confidence Interval	(2-Sided) 95.1%; -14.7 to -1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs >55 letters) as the stratification factor.

5. Secondary Outcome

Title	Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52
Description	NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed.

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.	Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
Measure Participants	250	253	273
Least Squares Mean (Standard Error) [score on a scale]	2.7 (0.7)	3.7 (0.7)	4.6 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95.1%; -3.7 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab 0.5 mg (rQ4)
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95.1%; -2.7 to 1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.9
	Estimation Comments	MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.

Adverse Events

Time Frame	From first dose to last dose of study drug (Up to Week 104)
Adverse Event Reporting Description	Safety population included all treated participants.
Arm/Group Title	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab 0.5 mg (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 8 and every 8 weeks (2Q8) thereafter through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.		Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, Week 12, and every 12 weeks (2Q12) thereafter through week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered.		Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96.
All Cause Mortality
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab 0.5 mg (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/312 (2.6%)		7/312 (2.2%)		11/310 (3.5%)
Serious Adverse Events
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab 0.5 mg (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	92/312 (29.5%)		102/312 (32.7%)		95/310 (30.6%)
Blood and lymphatic system disorders
Anaemia	1/312 (0.3%)		2/312 (0.6%)		4/310 (1.3%)
Neutropenia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Pancytopenia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Iron deficiency anaemia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Cardiac disorders
Atrial fibrillation	3/312 (1%)		4/312 (1.3%)		4/310 (1.3%)
Coronary artery disease	1/312 (0.3%)		2/312 (0.6%)		3/310 (1%)
Cardiac failure congestive	2/312 (0.6%)		3/312 (1%)		2/310 (0.6%)
Acute myocardial infarction	1/312 (0.3%)		3/312 (1%)		2/310 (0.6%)
Angina pectoris	0/312 (0%)		1/312 (0.3%)		2/310 (0.6%)
Cardiac failure	1/312 (0.3%)		0/312 (0%)		2/310 (0.6%)
Arrhythmia	0/312 (0%)		0/312 (0%)		2/310 (0.6%)
Angina unstable	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Atrioventricular block second degree	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Myocardial infarction	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Aortic valve incompetence	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Cardiac disorder	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Cardiomyopathy	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Hypertensive heart disease	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Supraventricular tachycardia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Ventricular tachycardia	0/312 (0%)		2/312 (0.6%)		0/310 (0%)
Left ventricular failure	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Mitral valve incompetence	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Aortic valve stenosis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Mitral valve prolapse	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Myocardial ischaemia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Arteriosclerosis coronary artery	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Atrial flutter	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Cardiac tamponade	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Eye disorders
Retinal artery occlusion	1/312 (0.3%)		3/312 (1%)		1/310 (0.3%)
Retinal haemorrhage	4/312 (1.3%)		1/312 (0.3%)		1/310 (0.3%)
Neovascular age-related macular degeneration	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Retinal pigment epithelial tear	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Macular degeneration	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Vitreous haemorrhage	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Uveitis	10/312 (3.2%)		10/312 (3.2%)		0/310 (0%)
Iridocyclitis	1/312 (0.3%)		4/312 (1.3%)		0/310 (0%)
Retinal vasculitis	6/312 (1.9%)		3/312 (1%)		0/310 (0%)
Visual acuity reduced	4/312 (1.3%)		3/312 (1%)		0/310 (0%)
Vitritis	5/312 (1.6%)		2/312 (0.6%)		0/310 (0%)
Cataract	3/312 (1%)		1/312 (0.3%)		0/310 (0%)
Autoimmune uveitis	2/312 (0.6%)		1/312 (0.3%)		0/310 (0%)
Eye pain	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Macular fibrosis	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Ocular hypertension	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Age-related macular degeneration	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Iritis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Macular scar	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Optic disc haemorrhage	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Optic ischaemic neuropathy	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Vitreous adhesions	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Retinal detachment	3/312 (1%)		0/312 (0%)		0/310 (0%)
Dacryostenosis acquired	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Diplopia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Glaucoma	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Lacrimation increased	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Necrotising retinitis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Photopsia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Retinal oedema	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Retinal tear	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Retinal vein occlusion	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Subretinal fibrosis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Visual impairment	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/312 (0.3%)		1/312 (0.3%)		2/310 (0.6%)
Colitis	0/312 (0%)		0/312 (0%)		2/310 (0.6%)
Abdominal pain upper	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Vomiting	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Constipation	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Femoral hernia incarcerated	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Functional gastrointestinal disorder	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Gingival bleeding	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Haematochezia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Inguinal hernia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Intestinal infarction	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Obstructive pancreatitis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Rectal haemorrhage	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Small intestinal obstruction	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Nausea	0/312 (0%)		2/312 (0.6%)		0/310 (0%)
Abdominal pain	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Anal fistula	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Colitis ischaemic	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Diarrhoea	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Gastritis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Gastrointestinal polyp haemorrhage	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Haemorrhoids	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Oesophageal stenosis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Barrett's oesophagus	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Haematemesis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Incarcerated inguinal hernia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Oesophageal spasm	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
General disorders
Non-cardiac chest pain	2/312 (0.6%)		0/312 (0%)		1/310 (0.3%)
Death	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Pyrexia	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Asthenia	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Chest pain	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Multiple organ dysfunction syndrome	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Fatigue	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Oedema peripheral	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Hepatobiliary disorders
Cholecystitis acute	2/312 (0.6%)		0/312 (0%)		1/310 (0.3%)
Cholecystitis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Hepatic mass	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Biliary dilatation	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Infections and infestations
Pneumonia	9/312 (2.9%)		9/312 (2.9%)		14/310 (4.5%)
Endophthalmitis	1/312 (0.3%)		4/312 (1.3%)		2/310 (0.6%)
Sepsis	1/312 (0.3%)		2/312 (0.6%)		2/310 (0.6%)
Urinary tract infection	1/312 (0.3%)		1/312 (0.3%)		2/310 (0.6%)
Bronchitis	1/312 (0.3%)		5/312 (1.6%)		1/310 (0.3%)
Cellulitis	2/312 (0.6%)		0/312 (0%)		1/310 (0.3%)
Device related infection	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Erysipelas	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Febrile infection	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Gastroenteritis viral	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Infective exacerbation of chronic obstructive airways disease	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Pneumonia viral	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Postoperative wound infection	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Tooth infection	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Wound infection	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Diverticulitis	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Appendicitis perforated	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Endocarditis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Gastroenteritis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Herpes zoster	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Influenza	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Localised infection	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Periorbital cellulitis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Peritonsillar abscess	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Pneumonia bacterial	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Pulmonary tuberculosis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Tonsillitis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Septic shock	2/312 (0.6%)		0/312 (0%)		0/310 (0%)
Abscess jaw	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Clostridium difficile infection	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Pulmonary sepsis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Respiratory tract infection	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Retinitis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Tracheobronchitis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Urinary tract infection enterococcal	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Injury, poisoning and procedural complications
Fall	0/312 (0%)		1/312 (0.3%)		5/310 (1.6%)
Hip fracture	1/312 (0.3%)		3/312 (1%)		3/310 (1%)
Fractured sacrum	0/312 (0%)		1/312 (0.3%)		2/310 (0.6%)
Ulna fracture	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Upper limb fracture	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Ankle fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Cataract operation complication	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Femur fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Lower limb fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Pelvic fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Pubis fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Rib fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Spinal compression fracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Femoral neck fracture	0/312 (0%)		3/312 (1%)		0/310 (0%)
Meniscus injury	0/312 (0%)		2/312 (0.6%)		0/310 (0%)
Radius fracture	0/312 (0%)		2/312 (0.6%)		0/310 (0%)
Contusion	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Fibula fracture	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Foot fracture	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Hand fracture	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Inflammation of wound	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Joint injury	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Periprosthetic fracture	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Procedural pneumothorax	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Subdural haemorrhage	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Incisional hernia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Ocular procedural complication	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Procedural nausea	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Procedural vomiting	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Spinal column injury	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Thermal burn	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Traumatic intracranial haemorrhage	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Investigations
Heart rate increased	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Intraocular pressure increased	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Blood pressure increased	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Metabolism and nutrition disorders
Dehydration	1/312 (0.3%)		3/312 (1%)		2/310 (0.6%)
Adult failure to thrive	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Hyperkalaemia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Hyponatraemia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Diabetes mellitus inadequate control	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/312 (0.6%)		1/312 (0.3%)		3/310 (1%)
Back pain	0/312 (0%)		0/312 (0%)		3/310 (1%)
Arthralgia	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Intervertebral disc protrusion	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Dupuytren's contracture	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Lumbar spinal stenosis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Musculoskeletal chest pain	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Rhabdomyolysis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Spinal column stenosis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Ankle deformity	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Pain in extremity	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Sacroiliitis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/312 (0.3%)		0/312 (0%)		3/310 (1%)
Renal cancer	0/312 (0%)		1/312 (0.3%)		2/310 (0.6%)
Metastases to bone	1/312 (0.3%)		0/312 (0%)		2/310 (0.6%)
Lung carcinoma cell type unspecified stage IV	0/312 (0%)		0/312 (0%)		2/310 (0.6%)
Breast cancer	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Breast cancer metastatic	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Squamous cell carcinoma	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Transitional cell carcinoma	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Adenocarcinoma of colon	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Adenocarcinoma pancreas	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Bone sarcoma	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Breast cancer female	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Clear cell renal cell carcinoma	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Gastric cancer stage IV	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Gastrointestinal carcinoma	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Lung neoplasm malignant	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Oesophageal adenocarcinoma	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Renal neoplasm	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Prostate cancer	0/312 (0%)		2/312 (0.6%)		0/310 (0%)
Bladder cancer	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Bowen's disease	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Cholangiocarcinoma	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Gastrointestinal stromal tumour	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Lung adenocarcinoma stage IV	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Malignant melanoma	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Ovarian cancer metastatic	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Plasma cell myeloma	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Small cell lung cancer metastatic	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Squamous cell carcinoma of lung	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Acute myeloid leukaemia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Benign neoplasm of skin	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Bladder neoplasm	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Bone cancer	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Colon cancer	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Head and neck cancer metastatic	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Lung adenocarcinoma	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Lung cancer metastatic	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Metastases to adrenals	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Renal cell carcinoma	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Spinal cord neoplasm	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Testis cancer	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Tonsil cancer	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Nervous system disorders
Cerebrovascular accident	2/312 (0.6%)		2/312 (0.6%)		5/310 (1.6%)
Carotid artery stenosis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Cognitive disorder	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Haemorrhagic stroke	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Hepatic encephalopathy	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Ischaemic stroke	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Lacunar infarction	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Metabolic encephalopathy	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Polyneuropathy	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Transient ischaemic attack	1/312 (0.3%)		2/312 (0.6%)		0/310 (0%)
Lumbar radiculopathy	1/312 (0.3%)		1/312 (0.3%)		0/310 (0%)
Generalised tonic-clonic seizure	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Quadrantanopia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Syncope	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Dementia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Hypoaesthesia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Myelopathy	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Optic neuritis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Psychiatric disorders
Depression	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Suicide attempt	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Intensive care unit delirium	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Completed suicide	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Mental status changes	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Renal and urinary disorders
Acute kidney injury	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Chronic kidney disease	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Nephritis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Nephrolithiasis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Bladder prolapse	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Urinary retention	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/312 (0.3%)		1/312 (0.3%)		1/310 (0.3%)
Prostatitis	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	4/312 (1.3%)		1/312 (0.3%)		5/310 (1.6%)
Pleural effusion	0/312 (0%)		0/312 (0%)		3/310 (1%)
Dyspnoea	0/312 (0%)		0/312 (0%)		2/310 (0.6%)
Pulmonary embolism	0/312 (0%)		0/312 (0%)		2/310 (0.6%)
Pulmonary oedema	2/312 (0.6%)		2/312 (0.6%)		1/310 (0.3%)
Respiratory failure	0/312 (0%)		1/312 (0.3%)		1/310 (0.3%)
Bronchospasm	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Pulmonary mass	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Respiratory disorder	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Bronchopneumopathy	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Pneumonia aspiration	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Pneumothorax	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Pulmonary congestion	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Acute respiratory distress syndrome	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Acute respiratory failure	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Hypoxia	1/312 (0.3%)		0/312 (0%)		0/310 (0%)
Skin and subcutaneous tissue disorders
Panniculitis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Vascular disorders
Aortic aneurysm	1/312 (0.3%)		2/312 (0.6%)		2/310 (0.6%)
Aortic stenosis	0/312 (0%)		2/312 (0.6%)		1/310 (0.3%)
Hypertension	2/312 (0.6%)		0/312 (0%)		1/310 (0.3%)
Hypotension	1/312 (0.3%)		0/312 (0%)		1/310 (0.3%)
Deep vein thrombosis	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Peripheral vascular disorder	0/312 (0%)		0/312 (0%)		1/310 (0.3%)
Haematoma	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Hypertensive crisis	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Peripheral ischaemia	0/312 (0%)		1/312 (0.3%)		0/310 (0%)
Other (Not Including Serious) Adverse Events
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab 0.5 mg (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	202/312 (64.7%)		217/312 (69.6%)		196/310 (63.2%)
Eye disorders
Conjunctival haemorrhage	27/312 (8.7%)		32/312 (10.3%)		46/310 (14.8%)
Neovascular age-related macular degeneration	26/312 (8.3%)		28/312 (9%)		39/310 (12.6%)
Eye pain	26/312 (8.3%)		26/312 (8.3%)		22/310 (7.1%)
Cataract	29/312 (9.3%)		19/312 (6.1%)		20/310 (6.5%)
Visual acuity reduced	24/312 (7.7%)		33/312 (10.6%)		18/310 (5.8%)
Vitreous detachment	19/312 (6.1%)		21/312 (6.7%)		17/310 (5.5%)
Retinal haemorrhage	16/312 (5.1%)		23/312 (7.4%)		16/310 (5.2%)
Vitreous floaters	22/312 (7.1%)		20/312 (6.4%)		16/310 (5.2%)
Eye irritation	11/312 (3.5%)		16/312 (5.1%)		9/310 (2.9%)
Subretinal fluid	8/312 (2.6%)		17/312 (5.4%)		7/310 (2.3%)
Iridocyclitis	10/312 (3.2%)		18/312 (5.8%)		2/310 (0.6%)
Infections and infestations
Nasopharyngitis	37/312 (11.9%)		36/312 (11.5%)		36/310 (11.6%)
Urinary tract infection	19/312 (6.1%)		21/312 (6.7%)		31/310 (10%)
Influenza	15/312 (4.8%)		16/312 (5.1%)		24/310 (7.7%)
Bronchitis	23/312 (7.4%)		19/312 (6.1%)		23/310 (7.4%)
Conjunctivitis	21/312 (6.7%)		20/312 (6.4%)		11/310 (3.5%)
Injury, poisoning and procedural complications
Fall	11/312 (3.5%)		12/312 (3.8%)		17/310 (5.5%)
Investigations
Intraocular pressure increased	15/312 (4.8%)		25/312 (8%)		13/310 (4.2%)
Musculoskeletal and connective tissue disorders
Back pain	14/312 (4.5%)		21/312 (6.7%)		13/310 (4.2%)
Respiratory, thoracic and mediastinal disorders
Cough	14/312 (4.5%)		18/312 (5.8%)		10/310 (3.2%)
Vascular disorders
Hypertension	25/312 (8%)		20/312 (6.4%)		28/310 (9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.