BALATON: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04740905
• Collaborator: Chugai Pharmaceutical (Industry)
• Enrollment: 553
• Locations: 152
• Arms: 2
• Anticipated Duration (Months): 27.4
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Branch Retinal Vein Occlusion	Drug: Faricimab; Drug: Aflibercept; Procedure: Sham Procedure	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 553 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
• Actual Study Start Date: Mar 2, 2021
• Actual Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	Drug: Faricimab; Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.; Other Names: RO6867461 RG7716 ; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	Drug: Faricimab; Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.; Other Names: RO6867461 RG7716 ; Drug: Aflibercept; Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).; Other Names: Eylea ; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [Baseline and Week 24]

Secondary Outcome Measures

1. Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

2. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [Baseline and Week 24]

3. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

4. Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

5. Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

6. Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

7. Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

8. Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

9. Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

10. Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

11. Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

12. Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

13. Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

14. Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

15. Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]

16. Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

17. Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [Baseline and Week 72]

18. Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

19. Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

20. Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

21. Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

22. Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

23. Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

24. Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

25. Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

26. Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

27. Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

28. Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]

29. Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

30. Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

31. Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

32. Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

33. Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]

34. Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [Week 72]

35. Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [From Week 24 to Week 72]

36. Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

37. Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]

38. Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]

39. Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]

40. Plasma Concentration of Faricimab Over Time [Predose at Day 1, Weeks 4, 24, 28, 52, and 72]

41. Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit

• Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1

• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

Exclusion Criteria:

• Any major illness or major surgical procedure within 1 month before screening

• Uncontrolled blood pressure

• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1

• Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

• History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening

• Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)

• Macular laser (focal/grid) in the study eye at any time prior to Day 1

• Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1

• Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection

• Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy

• Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

• Prior IVT administration of faricimab in either eye

• History of idiopathic or autoimmune-associated uveitis in either eye

• Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Research Institute, LLC	Phoenix	Arizona	United States	85014
2	Retina Associates Southwest PC	Tucson	Arizona	United States	85704
3	Retinal Diagnostic Center	Campbell	California	United States	95008
4	The Retina Partners	Encino	California	United States	91436
5	California Eye Specialists Medical group Inc.	Pasadena	California	United States	91107
6	Retina Consultants, San Diego	Poway	California	United States	92064
7	Retina Consultants of Southern Colorado PC	Colorado Springs	Colorado	United States	80909
8	Retina Group of New England	Waterford	Connecticut	United States	06385
9	Florida Eye Associates	Melbourne	Florida	United States	32901
10	Fort Lauderdale Eye Institute	Plantation	Florida	United States	33324
11	Retina Vitreous Assoc of FL	Saint Petersburg	Florida	United States	33711
12	Southern Vitreoretinal Assoc	Tallahassee	Florida	United States	32308
13	Retina Associates of Florida, LLC	Tampa	Florida	United States	33609
14	Southeast Retina Center	Augusta	Georgia	United States	30909
15	Georgia Retina PC	Marietta	Georgia	United States	30060
16	Retina Consultants of Hawaii	'Aiea	Hawaii	United States	96701
17	University Retina and Macula Associates, PC	Lemont	Illinois	United States	60439
18	Prairie Retina Center	Springfield	Illinois	United States	62704
19	Maine Eye Center	Portland	Maine	United States	04101
20	Cumberland Valley Retina PC	Hagerstown	Maryland	United States	21740
21	Tufts Medical Center; Ophthalmology	Boston	Massachusetts	United States	02111
22	Assoc Retinal Consultants PC	Royal Oak	Michigan	United States	48073
23	VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota	Edina	Minnesota	United States	55435
24	Midwest Vision Research Foundation	Chesterfield	Missouri	United States	63017
25	Sierra Eye Associates	Reno	Nevada	United States	89502
26	Retina Associates of NJ	Teaneck	New Jersey	United States	07666
27	Long Is. Vitreoretinal Consult	Great Neck	New York	United States	11021
28	Retina Vit Surgeons/Central NY	Liverpool	New York	United States	13088
29	Graystone Eye	Hickory	North Carolina	United States	28602
30	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
31	Black Hills Eye Institute	Rapid City	South Dakota	United States	57701
32	Charles Retina Institute	Memphis	Tennessee	United States	38119
33	Tennessee Retina PC	Nashville	Tennessee	United States	37203
34	Retina Res Institute of Texas	Abilene	Texas	United States	79606
35	Austin Retina Associates	Austin	Texas	United States	78705
36	Retina Consultants of Texas	Bellaire	Texas	United States	77401
37	Texas Retina Associates	Dallas	Texas	United States	75231
38	Retina & Vitreous of Texas	Houston	Texas	United States	77025
39	Strategic Clinical Research Group, LLC	Willow Park	Texas	United States	76087
40	Retina Associates of Utah	Salt Lake City	Utah	United States	84107
41	Organizacion Medica de Investigacion	Buenos Aires		Argentina	C1015ABO
42	Fundacion Zambrano	Caba		Argentina	C1017AAO
43	Centro Oftalmológico Dr. Charles S.A.	Capital Federal		Argentina	C1015ABO
44	Oftalmos	Capital Federal		Argentina	C1120AAN
45	Hospital Italiano; Ophtalmology	Capital Federal		Argentina	C1199ABC
46	Buenos Aires Mácula	Ciudad Autonoma Buenos Aires		Argentina	C1061AAE
47	Oftar	Mendoza		Argentina	M5500GGK
48	Centro Oftalmólogos Especialistas	Rosario		Argentina	S2000ANJ
49	Grupo Laser Vision	Rosario		Argentina	S2000DLA
50	Strathfield Retina Clinic	Strathfield	New South Wales	Australia	2135
51	Save Sight Institute	Sydney	New South Wales	Australia	2000
52	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales	Australia	2000
53	Centre For Eye Research Australia	East Melbourne	Victoria	Australia	3002
54	Retina Specialists Victoria	Rowville	Victoria	Australia	3178
55	The Lions Eye Institute	Nedlands	Western Australia	Australia	6009
56	LKH-Univ.Klinikum Graz; Universitäts-Augenklinik	Graz		Austria	8036
57	Hospital das Clinicas - UFRGS	Porto Alegre	RS	Brazil	90035-903
58	Botelho Hospital da Visao	Blumenau	SC	Brazil	89052-504
59	Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia	Sao Paulo	SP	Brazil	04023-062
60	Hosp de Olhos de Sorocaba	Sorocaba	SP	Brazil	18031-060
61	Beijing Hospital of Ministry of Health	Beijing		China	100730
62	The Second Hospital of Jilin University	Changchun		China	130041
63	West China Hospital, Sichuan University	Chengdu		China	610041
64	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou City		China	510060
65	The 2nd Affiliated Hospital of Harbin Medical University	Harbin		China	150001
66	The Affiliated Eye Hospital of Nanjing Medical University	Nanjing City		China	210029
67	Shanghai Tenth People's Hospital	Shanghai		China	200072
68	Shanghai First People's Hospital	Shanghai		China	200080
69	He Eye Specialist Shenyang Hospital	Shenyang City		China	110034
70	Tianjin Eye Hospital	Tianjin City		China	300050
71	Tianjin Medical University Eye Hospital	Tianjin City		China	300070
72	Eye Hospital, Wenzhou Medical University	Wenzhou City		China	325027
73	Renmin Hospital of Wuhan University	Wuhan		China	430060
74	Henan Provincial Eye Hosptial	Zhengzhou		China
75	Faculty Hospital Ostrava; Ophthalmology clinic	Ostrava		Czechia	708 52
76	Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic	Prague		Czechia	100 34
77	AXON Clinical	Prague		Czechia
78	Nemocnice Sokolov	Sokolov		Czechia	356 01
79	Chi De Creteil; Ophtalmologie	Creteil		France	94010
80	Hopital Lariboisiere; Ophtalmologie	Paris		France	75010
81	Universitätsklinikum Freiburg, Klinik für Augenheilkunde	Freiburg		Germany	79106
82	Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266	Göttingen		Germany	37075
83	Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik	Ludwigshafen		Germany	67063
84	Queen Mary Hospital; Department of Ophthalmology	Hong Kong		Hong Kong
85	Hong Kong Eye Hospital; CUHK Eye Centre	Mongkok		Hong Kong
86	Budapest Retina Associates Kft.	Budapest		Hungary	1133
87	Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika	Debrecen		Hungary	4032
88	Ganglion Medial Center	Pécs		Hungary	7621
89	Szegedi Tudományegyetem ÁOK; Department of Ophtalmology	Szeged		Hungary	6720
90	Rambam Medical Center; Opthalmology	Haifa		Israel	3109601
91	Hadassah MC; Ophtalmology	Jerusalem		Israel	9112001
92	Rabin MC; Ophtalmology	Petach Tikva		Israel	4941492
93	Kaplan Medical Center; Ophtalmology	Rehovot		Israel	7660101
94	Tel Aviv Sourasky MC; Ophtalmology	Tel Aviv		Israel	6423906
95	Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche	Roma	Lazio	Italy	00133
96	Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica	Milano	Lombardia	Italy	20100
97	Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica	Firenze	Toscana	Italy	50134
98	Sugita Eye Hospital	Aichi		Japan	460-0008
99	Nagoya University Hospital	Aichi		Japan	466-8560
100	Nagoya City University Hospital	Aichi		Japan	467-8602
101	Aichi Medical University Hospital	Aichi		Japan	480-1195
102	Toho University Sakura Medical Center	Chiba		Japan	285-8741
103	Hayashi Eye Hospital	Fukuoka		Japan	812-0011
104	Southern TOHOKU Eye Clinic	Fukushima		Japan	963-8052
105	Asahikawa Medical University Hospital	Hokkaido		Japan	078-8510
106	Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)	Hyogo		Japan	660-8550
107	Hyogo Medical University Hospital	Hyogo		Japan	663-8501
108	Kozawa eye hospital and diabetes center	Ibaraki		Japan	310-0845
109	Kyoto University Hospital	Kyoto		Japan	606-8507
110	Tokushima University Hospital	Tokushima		Japan	770-8503
111	Nihon University Hospital	Tokyo		Japan	101-8309
112	Tokyo Medical University Hachioji Medical Center	Tokyo		Japan	193-0998
113	Pusan National University Hospital	Busan		Korea, Republic of	49241
114	Yeungnam University Medical Center	Daegu		Korea, Republic of	42415
115	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13605
116	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
117	Asan Medical Center	Seoul		Korea, Republic of	05505
118	Samsung Medical Center	Seoul		Korea, Republic of	06351
119	Specjalistyczny Ośrodek Okulistyczny Oculomedica	Bydgoszcz		Poland	85-870
120	Szpital Specjalistyczny nr 1; Oddzial Okulistyki	Bytom		Poland	41-902
121	Dobry Wzrok Sp Z O O	Gdańsk		Poland	80-402
122	Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT	Gliwice		Poland	44-100
123	Gabinet Okulistyczny Prof Edward Wylegala	Katowice		Poland	40-594
124	Centrum Medyczne Dietla 19 Sp. Z O.O.	Kraków		Poland	31-070
125	Centrum Medyczne Pulawska SP. z o.o.	Piaseczno		Poland	05-500
126	Lens Clinic	Rybnik		Poland	44-203
127	Caminomed	Tarnowskie Góry		Poland	42-600
128	Centrum Zdrowia MDM	Warszawa		Poland	00-631
129	Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia	Coimbra		Portugal	3000-075
130	Espaco Medico Coimbra	Coimbra		Portugal	3030-163
131	Centro Hospitalar Universitário do Porto - Hospital de Santo António; Servico de Oftalmologia	Porto		Portugal	4099-001
132	Clinic Optimed	UFA	Baskortostan	Russian Federation	450059
133	Clinics of Eye Diseases, LLC	Kazan	Tatarstan	Russian Federation	420066
134	"Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch	Irkutsk		Russian Federation	664033
135	Singapore Eye Research Institute	Singapore		Singapore	168751
136	Tan Tock Seng Hospital; Ophthalmology Department	Singapore		Singapore	308433
137	Clinica Universitaria de Navarra; Servicio de Oftalmologia	Pamplona	Navarra	Spain	31008
138	Clinica Universitaria de Navarra	Pamplona	Navarra	Spain	31008
139	Oftalvist Valencia	Burjassot	Valencia	Spain	46100
140	Hospital dos de maig; servicio de oftalmologia	Barcelona		Spain	08025
141	Clinica Baviera; Servicio Oftalmologia	Madrid		Spain	28046
142	Hospital Universitario Rio Hortega; Servicio de Oftalmologia	Valladolid		Spain	47012
143	Changhua Christian Hospital; Department of Ophthalmology	Changhua		Taiwan	500
144	Taipei Veterans General Hospital; Ophthalmology	Taipei		Taiwan	11217
145	Chang Gung Medical Foundation - Linkou; Ophthalmology	Taoyuan		Taiwan	333
146	National Taiwan University Hospital; Ophthalmology	Zhongzheng Dist.		Taiwan	10002
147	Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL	Belfast		United Kingdom	BT12 6BA
148	Bristol Eye Hospital;Retinal Treatment and Research Unit	Bristol		United Kingdom	BS1 2LX
149	University Hospital of Wales	Cardiff		United Kingdom	CF14 4XW
150	Gloucestershire Hospitals NHS Foundation Trust	Gloucestershire		United Kingdom	GL1 3NN
151	St James University Hospital	Leeds		United Kingdom	LS9 7TF
152	Central Middlesex Hospital	London		United Kingdom	NW10 7NS

Sponsors and Collaborators

• Hoffmann-La Roche
• Chugai Pharmaceutical

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT04740905
• Other Study ID Numbers: GR41984; 2020-000440-63
• First Posted: Feb 5, 2021
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hoffmann-La Roche: BRVO
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Aflibercept

Study Results

No Results Posted as of Aug 8, 2022