Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02462486
• Collaborator: (none)
• Enrollment: 949
• Locations: 187
• Arms: 3
• Actual Duration (Months): 47.4
• Patients Per Site: 5.1
• 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: 949 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration (SEQUOIA Study)
• Actual Study Start Date: Jun 25, 2015
• Actual Primary Completion Date: Apr 12, 2018
• Actual Study Completion Date: Jun 6, 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, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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 (rQ4) Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks 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 vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is 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 percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

Secondary Outcome Measures

1. Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52 [Baseline to Week 52]

   BCVA was measured using an eye chart and is 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. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

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 that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.

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

   BCVA is measured using an eye chart and is 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 gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.

4. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score 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. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: 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	Eye Foundation Hospital	Birmingham	Alabama	United States	35233
2	Retinal Consultants of Arizona	Gilbert	Arizona	United States	85296
3	Barnet Dulaney Perkins Eye Center - Phoenix	Phoenix	Arizona	United States	85016-4701
4	Retina Centers, PC	Tucson	Arizona	United States	85704
5	Northwest Arkansas Retina Associates	Springdale	Arkansas	United States	72762
6	Win Retina	Arcadia	California	United States	91006
7	Retina Institute of California	Arcadia	California	United States	91007
8	Retinal Diagnostic Center	Campbell	California	United States	95008
9	Specialty Eye Care Medical Center, Inc.	Glendale	California	United States	91203
10	University of California at Irvine Gavin Herbert Eye Institute	Irvine	California	United States	92697-4375
11	Retina Associates of Orange County	Laguna Hills	California	United States	92653
12	South Coast Retina Center	Long Beach	California	United States	90807
13	East Bay Retina Consultants, Inc.	Oakland	California	United States	94609
14	San Diego Retina Associates	Oceanside	California	United States	92056
15	Southern California Desert Retina Consultants	Palm Desert	California	United States	92211
16	California Eye Specialist Medical Group	Pasadena	California	United States	91107
17	Retina Consultants, San Diego	Poway	California	United States	92064
18	Retina Consultants of Southern California	Redlands	California	United States	92374
19	Kaiser Permanente Riverside Medical Center	Riverside	California	United States	92505
20	UC Davis Medical Center, Department of Ophthalmology	Sacramento	California	United States	95817
21	Retinal Consultants Medical Group, Inc.	Sacramento	California	United States	95841
22	West Coast Retina Medical Group	San Francisco	California	United States	94109
23	Pacific Eye Associates	San Francisco	California	United States	94115
24	The Eye Associates	Bradenton	Florida	United States	34209
25	National Ophthalmic Research Institute	Fort Myers	Florida	United States	33912
26	Retina Macula Specialists of Miami	Miami	Florida	United States	33126
27	MedEye Associates	Miami	Florida	United States	33143
28	Fort Lauderdale Eye Institute	Plantation	Florida	United States	33324
29	Sarasota Retina Institute	Sarasota	Florida	United States	34239
30	East Florida Eye Institute	Stuart	Florida	United States	34994
31	Retina Associate of Florida, P.A.	Tampa	Florida	United States	33609
32	Retina Vitreous Associates of Florida	Tampa	Florida	United States	33617
33	Center for Retina and Macular Disease	Winter Haven	Florida	United States	33880
34	Southeast Retina Center	Augusta	Georgia	United States	30909
35	Rush University Medical Center	Chicago	Illinois	United States	60612
36	DuPage Medical Group	Downers Grove	Illinois	United States	60515
37	Kovach Eye Institute	Elmhurst	Illinois	United States	60126
38	University Retina and Macula Associates	Oak Forest	Illinois	United States	60452
39	Wheaton Eye Clinic, Clinical Research Center, LLC	Wheaton	Illinois	United States	60187
40	Sabates Eye Centers	Leawood	Kansas	United States	66211
41	Paducah Retinal Center	Paducah	Kentucky	United States	42001
42	The Retina Care Center	Baltimore	Maryland	United States	21209
43	Cumberland Valley Retina Consultants, P.C.	Hagerstown	Maryland	United States	21740
44	Vitreo-Retinal Associates, Pc	Worcester	Massachusetts	United States	01605
45	Retina Specialists of Michigan	Grand Rapids	Michigan	United States	49546
46	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
47	Retina Center of New Jersey, LLC	Bloomfield	New Jersey	United States	07003
48	Delaware Valley Retina Associates	Lawrenceville	New Jersey	United States	08648
49	Long Island Vitreoretinal Consultants	Hauppauge	New York	United States	11788
50	Maculacare - New York	New York	New York	United States	10021
51	Retina Vitreous Surgeons of Central NY, PC	Syracuse	New York	United States	13224
52	Western Carolina Retinal Associates, PA	Asheville	North Carolina	United States	28803
53	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina	United States	28210
54	Retina Associates of Cleveland, Inc	Beachwood	Ohio	United States	44122
55	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242-5664
56	Ohio State University	Columbus	Ohio	United States	43212
57	Midwest Retina, Inc.	Dublin	Ohio	United States	43016
58	Retina & Vitreous Center SO, PC	Ashland	Oregon	United States	97520
59	Oregon Health Sciences University	Portland	Oregon	United States	97239
60	Pennsylvania Retina Specialists, P.C.	Camp Hill	Pennsylvania	United States	17011
61	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
62	Austin Retina Associates	Austin	Texas	United States	78705
63	Retina and Vitreous of Texas	Beaumont	Texas	United States	77707
64	The University of Texas Medical Branch	Galveston	Texas	United States	77550
65	Premiere Retina Specialists	Midland	Texas	United States	79706
66	Retina Associates of South Texas, PA	San Antonio	Texas	United States	78240
67	Strategic Clinical Research Group, LLC	Willow Park	Texas	United States	76087
68	University of Utah, John Moran Eye Center	Salt Lake City	Utah	United States	84132
69	Virginia Eye Consultants	Norfolk	Virginia	United States	23502
70	Wagner Macula and Retina Center	Virginia Beach	Virginia	United States	23454
71	Vitreoretinal Associates of Washington	Bellevue	Washington	United States	98004
72	Spokane Eye Clinical Research	Spokane	Washington	United States	99204
73	West Virginia University Eye Institute	Morgantown	West Virginia	United States	26506
74	Save Sight Institute, University of Sydney Eye Hospital	Sydney	New South Wales	Australia	2000
75	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales	Australia	2000
76	Sydney West Retina	Westmead	New South Wales	Australia	2145
77	Centre for Eye Research Australia	East Melbourne	Victoria	Australia	3002
78	Specialist Eye Group	Glen Waverley	Victoria	Australia	3150
79	Lions Eye Institute	Nedlands	Western Australia	Australia	6009
80	Centro Brasileiro de Cirurgia de Olhos - CBCO	Goiania	Goias	Brazil	74210-010
81	Instistuto da Visao - Hospital de Olhos Ltda	Belo Horizonte	Minas Gerais	Brazil	30330-000
82	Hospital Oftalmologico de Sorocaba	Sorocaba	Sao Paulo	Brazil	18031-060
83	Clinica de Olhos Dr. Suel Abujamra	Sao Paulo		Brazil	01525-001
84	Instituto Da Visao UNIFESP EPM (Universidade Federal de Sao Paulo - Escola Paulista de Medicina)	Sao Paulo		Brazil	04023-062
85	Calgary Retina Consultants	Calgary	Alberta	Canada	T2H 0C8
86	St Joseph's Health Care London - Ivey Eye Institute	London	Ontario	Canada	N6A 4V2
87	Canadian Centre for Advanced Eye Therapeutics Inc	Mississauga	Ontario	Canada	L4W 1W9
88	University of Ottawa Eye Institute	Ottawa	Ontario	Canada	K1H 8L6
89	Toronto Retina Institute	Toronto	Ontario	Canada	M3C0G9
90	Rigshospitalet-Glostrup	Glostrup	Hovedstaden	Denmark	2600
91	Odense University Hospital	Odense	Syddanmark	Denmark	C 5000
92	Magyar Honvedseg Egeszegugyi Kozpont	Budapest		Hungary	1068
93	Semmelweis University	Budapest		Hungary	1085
94	Bajcsy-Zsilinszky Hospital	Budapest		Hungary	1106
95	Szent Imre Teaching Hospital	Budapest		Hungary	1115
96	Budapest Retina Associates Kft.	Budapest		Hungary	1133
97	University of Debrecen, Medical Center	Debrecen		Hungary	4032
98	Ganglion Medical Centre	Pecs		Hungary	7621
99	University of Szeged	Szeged		Hungary	6720
100	Markusovszki Teaching Hospital	Szombathely		Hungary	9700
101	Ospedale Clinicizzato	Chieti	Abruzzi	Italy	66100
102	Clinica Oculistica, Ospedale Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia	Italy	33100
103	Eye Clinic - Fondazione IRCCS	Milan	Lombardy	Italy	20122
104	Clinica Oculistica- Dipartimento di Scienze Cliniche Universita di Milano	Milan	Lombardy	Italy	20157
105	Ospedale Molinette	Torino	Piedmont	Italy	10126
106	Azienda Ospedaliero-Universitaria Careggi - SOD Oculistica, Dipartimento di Chirurgia e Medicina Traslazionale	Firenze	Tuscany	Italy	50134
107	Azienda Universitaria Ospedaliera Pisana, Ospedale "Nuovo S.Chiara" Cisanello	Pisa	Tuscany	Italy	56124
108	IRCCS - Istuto di Recovero e Cura a Carattere Scientifico	Verona	Vento	Italy	37024
109	A.O.U. Policlinico Sant Orsola Malpighi Pad1, 4Piano, Studio Medici via Pelagio Palagi 9	Bologna		Italy	40138
110	Clinica Oculistica DINOGMI Universita di Genova	Genova		Italy	16132
111	IRCCS Ospedale San Raffaele	Milano		Italy	20132
112	Policlinico Agostino Gemelli	Roma		Italy	00168
113	Fondazione G.B. Bietti-IRCCS	Roma		Italy	00198
114	Aichi Medical University Hospital	Nagakute	Aichi	Japan	480-1195
115	Japan Community Health Care Organization Chukyo Hospital	Nagoya	Aichi	Japan	457-8510
116	Nagoya University Hospital	Nagoya	Aichi	Japan	466-8560
117	Kameda Clinic	Kamogawa	Chiba	Japan	296-0041
118	Toho University Sakura Medical Center	Sakura	Chiba	Japan	285-8741
119	Juntendo University Urayasu Hospital	Urayasu	Chiba	Japan	279-0021
120	Ogaki Tokushukai Hospital	Ogaki	Gifu	Japan	503-0015
121	Kimura Eye And Internal Medicine Hospital	Kure	Hiroshima	Japan	737-0029
122	Sapporo City General Hospital	Sapporo	Hokkaido	Japan	060-8604
123	Hyogo Prefectural Amagasaki Hospital General Medical Center	Amagasaki	Hyogo	Japan	660-8550
124	Tokyo Medical University Ibaraki Medical Center	Inashiki	Ibaraki	Japan	300-0395
125	Mito Kyodo General Hospital	Mito	Ibaraki	Japan	310-0015
126	Otakeganka Tsukimino Clinic	Yamato	Kanagawa	Japan	242-0001
127	Kikuna Yuda Eye Clinic	Kanagawa	Kanto	Japan	222-0011
128	Mie University Hospital	Tsu	Mie	Japan	514-8507
129	Iida Municipal Hospital	Iida	Nagano	Japan	395-8502
130	Shiga University of Medical Science Hospital	Otsu	Shiga	Japan	520-2192
131	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka	Japan	430-8558
132	Nihon University Hospital	Chiyoda	Tokyo	Japan	101-8309
133	Chofu Eye Clinic	Chofu	Tokyo	Japan	182-0024
134	Tokyo Medical University Hachioji Medical Center	Hachioji	Tokyo	Japan	193-0998
135	Takeuchi Eye Clinic	Taito	Tokyo	Japan	111-0051
136	Kyushu University Hospital	Fukuoka		Japan	812-8582
137	Fukushima Medical University Hospital	Fukushima		Japan	960-1295
138	Kokura Kinen Hospital	Kitakyushu		Japan	802-8555
139	Ideta Eye Hospital	Kumamoto		Japan	860-0027
140	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki		Japan	852-0851
141	Nara Medical University Hospital	Nara		Japan	634-8522
142	Medical Corporation Jinshikai Nishi Eye Hospital	Osaka		Japan	537-0025
143	Musashi Dream Clinic	Osaka		Japan	543-0027
144	Tane Memorial Eye Hospital	Osaka		Japan	550-0024
145	Tokyo Women's Medical University Hospital	Tokyo		Japan	162-8666
146	Elisabeth Hospital	Tilburg	North Brabant	Netherlands	5022 GC
147	Academic Medical Center	Amsterdam	North Holland	Netherlands	1105 AZ
148	Oogziekenhuis Rotterdam	Rotterdam	North Holland	Netherlands	3011 BH
149	Leiden University Medical Center	Leiden	South Holland	Netherlands	2333 ZA
150	Macula D&T Eye Center	San Isidro	Lima	Peru	27
151	Optimum Profesorskie Centrum Okulistyki	Gdansk		Poland	80-809
152	Klinika Okulistyczna Jasne Blonia	Lodz		Poland	91-134
153	Centrum Diagnostyki i Mikrochirurgii	Olsztyn		Poland	10-424
154	Retina Eye Hospital	Warsaw		Poland	01-364
155	Uniwersytecki Szpital Kliniczny	Wrocław		Poland	50-556
156	Scientific Research Institute of Ocular Diseases of RAMS	Moscow		Russian Federation	119021
157	S. Fyodorov Eye Microsurgery Federal State Institution	Moscow		Russian Federation	127486
158	Pasteur Medical Centre	Bloemfontein		South Africa	9301
159	Dr Actons Privat Practice	Cape Town		South Africa	7530
160	Pretoria Eye Institute, Private Practice	Pretoria		South Africa	0007
161	Department of Ophthalmology Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	813
162	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833
163	Department of Ophthalmology National Taiwan University Hospital	Taipei		Taiwan	100
164	Shin Kong Wu Ho-Su Memorial Hospital	Taipei		Taiwan	111
165	Chang Gung Medical Foundation, Linkou Branch	Taoyuan		Taiwan	333
166	Ankara Uni Med Fac	Ankara		Turkey	06590
167	Dokuz Eylul Uni Med Fac	Izmir		Turkey	35340
168	Frimley Park Hospital	Frimley	Camberley	United Kingdom	GU17 7UJ
169	Royal Derby Hospital	Derby	Derbyshire	United Kingdom	DE22 3NE
170	ESNEFT Essex County Hospital	Colchester	Essex	United Kingdom	CO4 5JR
171	University Hospital Southampton	Southampton	Hampshire	United Kingdom	SO16 6YD
172	Oxford Eye Hospital, John Radcliffe Hospital	Oxford	Headington	United Kingdom	OX3 9DU
173	Royal Liverpool University Hospital	Liverpool	North West England	United Kingdom	L7 8XP
174	Royal Surrey Hospital	Guildford	South East	United Kingdom	S10 2TB
175	Heart of England NHS Foundation Trust, Good Hope Hospital	Sutton Coldfield	Staffordshire	United Kingdom	B75 7RR
176	University Hospital of Wales	Cardiff	Wales	United Kingdom	CF4 4XW
177	Bradford Royal Infirmary (BRI)	Bradford	West Yorkshire	United Kingdom	BD18 4JN
178	Sheffield Teaching Hospitals	Sheffield	Yorkshire	United Kingdom	S10 2TB
179	Barnet Hospital	Barnet		United Kingdom	EN5 3DJ
180	Bristol Eye Hospital	Bristol		United Kingdom	BS1 2LX
181	University Hospital Aintree	Liverpool		United Kingdom	L9 7AL
182	Moorfields Eye Hospital	London		United Kingdom	EC1V 2PD
183	Barnet Royal Free Hospital	London		United Kingdom	EN53DJ
184	King's College Hospital	London		United Kingdom	SE5 9RJ
185	Royal Victoria Infirmary	Newcastle		United Kingdom	NE1 4LP
186	Hospital of St. Cross	Rugby		United Kingdom	CV22 5PX
187	City Hospitals Sunderland NHS	Sunderland		United Kingdom	SR2 9HP

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: NCT02462486
• Other Study ID Numbers: 150998-006; 2014-004580-20; SEQUOIA
• First Posted: Jun 4, 2015
• Last Update Posted: Jul 30, 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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Period Title: Overall Study
STARTED	316	315	318
COMPLETED	222	223	266
NOT COMPLETED	94	92	52

Baseline Characteristics

Arm/Group Title	Abicipar Pegol 2 mg (2Q8)	Abicipar Pegol 2 mg (2Q12)	Ranibizumab (rQ4)	Total
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.	Total of all reporting groups
Overall Participants	316	315	318	949
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.9 (8.6)	76.2 (8.3)	75.9 (8.4)	76.0 (8.4)
Sex: Female, Male (Count of Participants)
Female	179 56.6%	174 55.2%	185 58.2%	538 56.7%
Male	137 43.4%	141 44.8%	133 41.8%	411 43.3%
Race/Ethnicity, Customized (Count of Participants)
White	266 84.2%	266 84.4%	264 83%	796 83.9%
Black	2 0.6%	4 1.3%	3 0.9%	9 0.9%
Asian	39 12.3%	35 11.1%	41 12.9%	115 12.1%
Hispanic	7 2.2%	8 2.5%	9 2.8%	24 2.5%
Other	2 0.6%	0 0%	0 0%	2 0.2%
Not Reported	0 0%	1 0.3%	1 0.3%	2 0.2%
Unknown	0 0%	1 0.3%	0 0%	1 0.1%
Best Corrected Visual Acuity (BCVA) for Per Protocol Population (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	57.8 (12.1)	56.3 (12.5)	57.0 (12.3)	57.0 (12.3)
BCVA for ITT Population (letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [letters]	57.2 (12.3)	56.4 (12.5)	57.1 (12.3)	56.9 (12.4)
Central Retinal Thickness (CRT) (microns) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [microns]	380.3 (117.9)	378.2 (123.8)	382.4 (130.3)	380.3 (124.0)
National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) (score on a scale) [Mean (Full Range) ]
Mean (Full Range) [score on a scale]	78.4	78.3	77.3	78

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Stable Vision at Week 52
Description	Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is 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 percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Measure Participants	267	265	299
Number [percentage of participants]	94.8 30%	91.3 29%	96.0 30.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -5.0 to 2.4
	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 (rQ4)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage Difference
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 95%; -9.0 to -0.5
	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 stratification factor.

2. Secondary Outcome

Title	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52
Description	BCVA was measured using an eye chart and is 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. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Measure Participants	248	251	287
Mean (Standard Deviation) [letters]	8.3 (14.3)	7.3 (13.8)	8.3 (11.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab (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 Mean Difference
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95.1%; -2.4 to 2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	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 (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 Mean Difference
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95.1%; -3.8 to 0.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	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 that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye. MMRM analysis was used.
Time Frame	Baseline to Week 52

Outcome Measure Data

Analysis Population Description

Intent-to-treat (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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Measure Participants	248	256	286
Mean (Standard Deviation) [microns]	-146.8 (118.1)	-141.7 (127.1)	-147.1 (126.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab (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	Least Squares Mean Difference
	Estimated Value	3.5
	Confidence Interval	(2-Sided) 95.1%; -7.1 to 14.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.4
	Estimation Comments	MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT 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 (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	Least Squares Mean Difference
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95.1%; -4.7 to 16.5
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.4
	Estimation Comments	MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.

4. Secondary Outcome

Title	Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52
Description	BCVA is measured using an eye chart and is 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 gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as 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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Measure Participants	316	315	318
Number [percentage of participants]	28.2 8.9%	24.4 7.7%	26.7 8.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab (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	1.4
	Confidence Interval	(2-Sided) 95%; -5.5 to 8.4
	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 (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	-2.3
	Confidence Interval	(2-Sided) 95%; -9.1 to 4.5
	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 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. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: 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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
Measure Participants	254	261	287
Least Squares Mean (Standard Error) [scores on a scale]	2.8 (0.7)	2.4 (0.7)	4.4 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q8), Ranibizumab (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	Least Squares Mean Difference
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95.1%; -3.5 to 0.3
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.0
	Estimation Comments	MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Abicipar Pegol 2 mg (2Q12), Ranibizumab (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	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95.1%; -3.9 to -0.1
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.0
	Estimation Comments	MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.

Adverse Events

Time Frame	From the first dose up to last dose (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 (rQ4)
Arm/Group Description	Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks 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, and Week 12, followed by injections every 12 weeks 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®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96.
All Cause Mortality
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/313 (3.5%)		6/314 (1.9%)		7/315 (2.2%)
Serious Adverse Events
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/313 (30%)		83/314 (26.4%)		78/315 (24.8%)
Blood and lymphatic system disorders
Anaemia	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Iron deficiency anaemia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Cardiac disorders
Cardiac failure congestive	3/313 (1%)		5/314 (1.6%)		5/315 (1.6%)
Atrial fibrillation	2/313 (0.6%)		3/314 (1%)		5/315 (1.6%)
Angina pectoris	1/313 (0.3%)		2/314 (0.6%)		3/315 (1%)
Coronary artery disease	1/313 (0.3%)		1/314 (0.3%)		2/315 (0.6%)
Arrhythmia	0/313 (0%)		1/314 (0.3%)		2/315 (0.6%)
Bradycardia	0/313 (0%)		0/314 (0%)		2/315 (0.6%)
Myocardial infarction	0/313 (0%)		4/314 (1.3%)		1/315 (0.3%)
Cardiac arrest	1/313 (0.3%)		1/314 (0.3%)		1/315 (0.3%)
Acute myocardial infarction	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Atrial flutter	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Myocardial oedema	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Ventricular tachycardia	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Cardiac failure	1/313 (0.3%)		2/314 (0.6%)		0/315 (0%)
Myocardial ischaemia	2/313 (0.6%)		1/314 (0.3%)		0/315 (0%)
Aortic valve disease	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Atrioventricular block complete	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Aortic valve incompetence	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Aortic valve stenosis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Atrioventricular block second degree	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Coronary artery occlusion	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Mitral valve incompetence	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Sinus bradycardia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Tachycardia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Ear and labyrinth disorders
Vertigo positional	1/313 (0.3%)		1/314 (0.3%)		1/315 (0.3%)
Meniere's disease	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Eye disorders
Retinal haemorrhage	2/313 (0.6%)		0/314 (0%)		5/315 (1.6%)
Retinal detachment	3/313 (1%)		0/314 (0%)		2/315 (0.6%)
Cataract	2/313 (0.6%)		3/314 (1%)		1/315 (0.3%)
Vitreous haemorrhage	0/313 (0%)		2/314 (0.6%)		1/315 (0.3%)
Retinal fibrosis	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Retinal pigment epithelial tear	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Uveitis	7/313 (2.2%)		4/314 (1.3%)		0/315 (0%)
Retinal vasculitis	4/313 (1.3%)		4/314 (1.3%)		0/315 (0%)
Visual acuity reduced	1/313 (0.3%)		3/314 (1%)		0/315 (0%)
Vitritis	4/313 (1.3%)		1/314 (0.3%)		0/315 (0%)
Iridocyclitis	2/313 (0.6%)		1/314 (0.3%)		0/315 (0%)
Retinal artery occlusion	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Age-related macular degeneration	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Autoimmune uveitis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Choroidal neovascularisation	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Neovascular age-related macular degeneration	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Retinal vein occlusion	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Anterior chamber inflammation	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Keratitis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Macular hole	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Serous retinal detachment	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	0/313 (0%)		1/314 (0.3%)		1/315 (0.3%)
Alcoholic pancreatitis	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Diverticulum	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Inguinal hernia	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Intestinal perforation	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Peritoneal haemorrhage	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Nausea	0/313 (0%)		2/314 (0.6%)		0/315 (0%)
Intestinal obstruction	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Colitis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Gastrointestinal haemorrhage	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pancreatitis acute	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Vomiting	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Abdominal pain upper	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Constipation	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Duodenal ulcer	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Gastrointestinal ulcer haemorrhage	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Large intestine polyp	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Pharyngo-oesophageal diverticulum	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
General disorders
Peripheral swelling	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Asthenia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Death	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Non-cardiac chest pain	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Hepatobiliary disorders
Cholecystitis acute	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Cholecystitis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Immune system disorders
Drug hypersensitivity	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Infections and infestations
Pneumonia	4/313 (1.3%)		3/314 (1%)		8/315 (2.5%)
Diverticulitis	0/313 (0%)		1/314 (0.3%)		2/315 (0.6%)
Endophthalmitis	5/313 (1.6%)		4/314 (1.3%)		1/315 (0.3%)
Sepsis	2/313 (0.6%)		0/314 (0%)		1/315 (0.3%)
Influenza	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Abdominal abscess	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Arteritis infective	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Enterocolitis viral	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Gastrointestinal infection	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Infective aortitis	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Pneumonia staphylococcal	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Cellulitis	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Cytomegalovirus infection	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pneumonia bacterial	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pneumonia escherichia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pneumonia pneumococcal	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pyelonephritis acute	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Septic shock	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Bronchitis	3/313 (1%)		0/314 (0%)		0/315 (0%)
Urinary tract infection	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Cellulitis staphylococcal	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Clostridium difficile colitis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Diarrhoea infectious	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Gastroenteritis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Infectious colitis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Pulmonary sepsis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Respiratory tract infection	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Injury, poisoning and procedural complications
Fall	2/313 (0.6%)		3/314 (1%)		3/315 (1%)
Subdural haematoma	0/313 (0%)		1/314 (0.3%)		2/315 (0.6%)
Femoral neck fracture	1/313 (0.3%)		1/314 (0.3%)		1/315 (0.3%)
Animal bite	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Cervical vertebral fracture	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Concussion	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Hip fracture	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Multiple fractures	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Scrotal haematoma	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Spinal compression fracture	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Synovial rupture	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Traumatic liver injury	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Vascular pseudoaneurysm	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Tibia fracture	0/313 (0%)		2/314 (0.6%)		0/315 (0%)
Foot fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Hand fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Incisional hernia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Lower limb fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Periprosthetic fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Radius fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Road traffic accident	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Skin laceration	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Skin wound	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Wrist fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Femur fracture	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Head injury	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Rib fracture	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Investigations
Troponin increased	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Intraocular pressure increased	1/313 (0.3%)		2/314 (0.6%)		0/315 (0%)
Heart rate decreased	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Monoclonal immunoglobulin present	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Blood glucose abnormal	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Blood pressure increased	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Pulmonary function test decreased	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Urine electrolytes decreased	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Metabolism and nutrition disorders
Dehydration	2/313 (0.6%)		2/314 (0.6%)		1/315 (0.3%)
Diabetes mellitus inadequate control	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Malnutrition	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Fluid overload	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Hypoglycaemia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Hypokalaemia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Vitamin B12 deficiency	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/313 (0.6%)		1/314 (0.3%)		2/315 (0.6%)
Rotator cuff syndrome	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Bone loss	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Musculoskeletal chest pain	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Muscular weakness	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Back pain	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Flank pain	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Foot fracture	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Haemarthrosis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Muscle spasms	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Spinal column stenosis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Spondylolisthesis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Synovial cyst	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Bursitis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Trigger finger	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	2/313 (0.6%)		3/314 (1%)		6/315 (1.9%)
Squamous cell carcinoma	1/313 (0.3%)		1/314 (0.3%)		2/315 (0.6%)
Squamous cell carcinoma of skin	0/313 (0%)		0/314 (0%)		2/315 (0.6%)
Lung neoplasm malignant	0/313 (0%)		2/314 (0.6%)		1/315 (0.3%)
Breast cancer	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Lung adenocarcinoma	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Prostate cancer	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Renal cancer metastatic	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Small cell lung cancer	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Keratoacanthoma	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Metastases to central nervous system	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Metastases to liver	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Retroperitoneal neoplasm metastatic	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Thyroid cancer	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Transitional cell carcinoma	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Myelodysplastic syndrome	0/313 (0%)		2/314 (0.6%)		0/315 (0%)
Bladder neoplasm	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Chronic lymphocytic leukaemia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Colorectal cancer metastatic	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Lung adenocarcinoma stage IV	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Meningioma	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Small cell lung cancer metastatic	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Squamous cell carcinoma of head and neck	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pancreatic carcinoma	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Bladder transitional cell carcinoma	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Bowen's disease	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Hepatic cancer	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Invasive ductal breast carcinoma	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Oropharyngeal squamous cell carcinoma	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Plasma cell myeloma	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Rectal cancer	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Nervous system disorders
Transient ischaemic attack	1/313 (0.3%)		1/314 (0.3%)		3/315 (1%)
Cerebrovascular accident	0/313 (0%)		3/314 (1%)		1/315 (0.3%)
Syncope	0/313 (0%)		1/314 (0.3%)		1/315 (0.3%)
Brain stem stroke	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Cerebral haemorrhage	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Lumbar radiculopathy	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Paraesthesia	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Piriformis syndrome	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Seizure	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Amnesia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Dizziness	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Hypoaesthesia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Optic neuritis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Peroneal nerve palsy	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Radiculopathy	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Vertebral artery occlusion	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Carotid artery occlusion	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Carotid artery stenosis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Carpal tunnel syndrome	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Cerebral infarction	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Headache	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Ischaemic stroke	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Speech disorder	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Vascular dementia	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Psychiatric disorders
Hallucination	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Mental status changes	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Depression	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Renal and urinary disorders
Nephrolithiasis	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Acute kidney injury	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Haematuria	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Reproductive system and breast disorders
Gynaecomastia	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Prostatomegaly	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/313 (0.6%)		3/314 (1%)		3/315 (1%)
Dyspnoea	1/313 (0.3%)		2/314 (0.6%)		2/315 (0.6%)
Acute respiratory failure	0/313 (0%)		2/314 (0.6%)		2/315 (0.6%)
Respiratory failure	0/313 (0%)		2/314 (0.6%)		1/315 (0.3%)
Hypoxia	1/313 (0.3%)		1/314 (0.3%)		1/315 (0.3%)
Pulmonary hypertension	0/313 (0%)		1/314 (0.3%)		1/315 (0.3%)
Pulmonary embolism	1/313 (0.3%)		0/314 (0%)		1/315 (0.3%)
Emphysema	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Pneumothorax spontaneous	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Respiratory distress	0/313 (0%)		2/314 (0.6%)		0/315 (0%)
Pleural effusion	1/313 (0.3%)		1/314 (0.3%)		0/315 (0%)
Epistaxis	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Pneumothorax	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Asthma	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Haemoptysis	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Vascular disorders
Hypertension	0/313 (0%)		2/314 (0.6%)		2/315 (0.6%)
Aortic stenosis	0/313 (0%)		1/314 (0.3%)		1/315 (0.3%)
Haematoma	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Hypertensive crisis	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Shock haemorrhagic	0/313 (0%)		0/314 (0%)		1/315 (0.3%)
Aortic aneurysm	0/313 (0%)		2/314 (0.6%)		0/315 (0%)
Blood pressure inadequately controlled	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Hypotension	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Peripheral ischaemia	0/313 (0%)		1/314 (0.3%)		0/315 (0%)
Deep vein thrombosis	2/313 (0.6%)		0/314 (0%)		0/315 (0%)
Aortic aneurysm rupture	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Lymphoedema	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Peripheral artery aneurysm	1/313 (0.3%)		0/314 (0%)		0/315 (0%)
Other (Not Including Serious) Adverse Events
	Abicipar Pegol 2 mg (2Q8)		Abicipar Pegol 2 mg (2Q12)		Ranibizumab (rQ4)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	168/313 (53.7%)		166/314 (52.9%)		166/315 (52.7%)
Eye disorders
Eye pain	37/313 (11.8%)		35/314 (11.1%)		36/315 (11.4%)
Conjunctival haemorrhage	24/313 (7.7%)		29/314 (9.2%)		29/315 (9.2%)
Conjunctival hyperaemia	17/313 (5.4%)		15/314 (4.8%)		23/315 (7.3%)
Neovascular age-related macular degeneration	18/313 (5.8%)		25/314 (8%)		21/315 (6.7%)
Vitreous floaters	27/313 (8.6%)		30/314 (9.6%)		17/315 (5.4%)
Vitreous detachment	16/313 (5.1%)		17/314 (5.4%)		11/315 (3.5%)
Visual acuity reduced	17/313 (5.4%)		15/314 (4.8%)		6/315 (1.9%)
Infections and infestations
Nasopharyngitis	33/313 (10.5%)		35/314 (11.1%)		40/315 (12.7%)
Influenza	19/313 (6.1%)		15/314 (4.8%)		22/315 (7%)
Urinary tract infection	22/313 (7%)		21/314 (6.7%)		12/315 (3.8%)
Injury, poisoning and procedural complications
Fall	13/313 (4.2%)		14/314 (4.5%)		22/315 (7%)
Investigations
Intraocular pressure increased	29/313 (9.3%)		29/314 (9.2%)		20/315 (6.3%)
Nervous system disorders
Headache	11/313 (3.5%)		18/314 (5.7%)		17/315 (5.4%)
Vascular disorders
Hypertension	18/313 (5.8%)		22/314 (7%)		16/315 (5.1%)

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.