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A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema (Meerkat)

Primary Purpose

Uveitic Macular Edema

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RO7200220
Sham
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitic Macular Edema

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol Diagnosis of macular edema associated with non-infectious uveitis (NIU) Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts Exclusion Criteria: Evidence of active or latent syphilis infection Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis Serious acute or chronic medical or psychiatric illness History of major ocular and non-ocular surgical procedures Uncontrolled IOP or glaucoma or chronic hypotony Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 Diagnosis of macular edema due to any cause other than NIU Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss

Sites / Locations

  • Kaiser Permanente Southern CaliforniaRecruiting
  • Colorado Retina Associates, PC
  • Retina Vitreous Associates of FloridaRecruiting
  • Cumberland Valley Retina PCRecruiting
  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of MinnesotaRecruiting
  • Truhlsen Eye InstituteRecruiting
  • Envision Ocular, LLCRecruiting
  • The Retina ConsultantsRecruiting
  • Wake Forest Baptist Health Eye CentreRecruiting
  • The Ohio State University Investigational Drug ServicesRecruiting
  • Oregon Health & Science UniRecruiting
  • Erie Retinal SurgeryRecruiting
  • Palmetto Retina CenterRecruiting
  • Tennessee Retina PCRecruiting
  • Vanderbilt Eye InstituteRecruiting
  • Austin Clinical Research LLCRecruiting
  • Texas Retina AssociatesRecruiting
  • Wagner Kapoor InstituteRecruiting
  • Spokane Eye Clinical ResearchRecruiting
  • LKH-Univ.Klinikum Graz; Universitäts-AugenklinikRecruiting
  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und OptometrieRecruiting
  • Alberta Retina ConsultantsRecruiting
  • Ivey Eye InstituteRecruiting
  • Kensington Vision and Research CentreRecruiting
  • McGill University Health CenterRecruiting
  • CHU de Quebec-Universite LavalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Beijing Tongren HospitalRecruiting
  • The Second Hospital of Jilin University; ophthalmology departmentRecruiting
  • The First Affiliated Hospital, Chongqing Medical UniversityRecruiting
  • Second Affiliated Hospital Zhejiang University College of Medicine; OphthalmologyRecruiting
  • Shanghai First People's HospitalRecruiting
  • Tianjin Medical University Eye HospitalRecruiting
  • Ren Min Hospital Affiliated Wu Han UniversityRecruiting
  • Wuxi No.2 People's HospitalRecruiting
  • Rambam Medical Center; OpthalmologyRecruiting
  • Hadassah MC; OphtalmologyRecruiting
  • Meir Medical Center; OphtalmologyRecruiting
  • Rabin MC; OphtalmologyRecruiting
  • Kaplan Medical Center; OphtalmologyRecruiting
  • Tel Aviv Sourasky MC; OphtalmologyRecruiting
  • AUSL ? IRCCS Santa Maria Nuova; Immunologia OculareRecruiting
  • Irccs Ospedale San Raffaele;U.O. OculisticaRecruiting
  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)Recruiting
  • Pusan National University HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Ajou University Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul St Mary's HospitalRecruiting
  • Kim's Eye HospitalRecruiting
  • Hospital de la Ceguera APECRecruiting
  • Instituto de Oftalmologia Monterrey - Vision100 (IOM)Recruiting
  • Het Oogziekenhuis RotterdamRecruiting
  • OFTALMIKA Sp. z o.oRecruiting
  • Gabinet Okulistyczny Prof Edward WylegalaRecruiting
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii OkulistycznejRecruiting
  • SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala SzklistegoRecruiting
  • SPEKTRUM Osrodek Okulistyki KlinicznejRecruiting
  • AIBILI - Association for Innovation and Biomedical Research on LightRecruiting
  • Instituto de Oftalmologia Dr. Gama PintoRecruiting
  • Hospital de Santa Maria; Servico de OftalmologiaRecruiting
  • Taipei Veterans General Hospital; OphthalmologyRecruiting
  • Mackay Memorial Hospital; OphthalmologyRecruiting
  • Chang Gung Medical Foundation - Linkou; Ophthalmology
  • Bradford Royal InfirmaryRecruiting
  • University Hospital of WalesRecruiting
  • Gloucestershire Hospitals NHS Foundation TrustRecruiting
  • Moorfields Eye Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Arm A

Arm B

Arm C

Arm Description

Participants will receive 4 low-dose RO7200220 intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.

Participants will receive 4 high-dose RO7200220 IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.

Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Outcomes

Primary Outcome Measures

Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16

Secondary Outcome Measures

Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Change from baseline in BCVA at Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Time to rescue treatment
Number of rescue treatments received
Type of rescue treatments received
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Number of PRN injections received
Time to first PRN injection
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Percentage of participants with non-ocular AEs
Percent change from baseline in corneal endothelial cell density at Week 24
Percentage of participants with adverse events of special interest (AESIs)
Percent change from baseline in corneal endothelial cell density at Week 52
Aqueous humor (AH) concentration of RO7200200
Serum concentration of RO7200220
Anti-drug antibody titer to RO7200220

Full Information

First Posted
December 6, 2022
Last Updated
October 23, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05642312
Brief Title
A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema
Acronym
Meerkat
Official Title
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Uveitic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Participants will receive 4 low-dose RO7200220 intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Participants will receive 4 high-dose RO7200220 IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Arm Title
Arm C
Arm Type
Sham Comparator
Arm Description
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
Intervention Type
Drug
Intervention Name(s)
RO7200220
Intervention Description
Participants will receive RO7200220 IVT injection
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Participants will receive a sham procedure that mimics an IVT injection.
Primary Outcome Measure Information:
Title
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Time Frame
Week 20
Title
Change from baseline in BCVA at Week 16
Time Frame
Week 16
Title
Change from baseline in central subfield thickness (CST) at Week 16
Time Frame
Week 16
Title
Change from Baseline in BCVA at Weeks 20 and 52
Time Frame
Weeks 20 and 52
Title
Change from baseline in CST at Weeks 20 and 52
Time Frame
Weeks 20 and 52
Title
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Time Frame
Weeks 16 and 52
Title
Time to rescue treatment
Time Frame
Up to Week 52
Title
Number of rescue treatments received
Time Frame
Up to Week 52
Title
Type of rescue treatments received
Time Frame
Up to Week 52
Title
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Time Frame
Weeks 16 and 52
Title
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Time Frame
Weeks 16 and 52
Title
Number of PRN injections received
Time Frame
Up to Week 52
Title
Time to first PRN injection
Time Frame
Up to Week 52
Title
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Time Frame
Weeks 16 and 52
Title
Percentage of participants with ocular adverse events (AEs)
Time Frame
Up to Week 52
Title
Percentage of participants with non-ocular AEs
Time Frame
Up to Week 52
Title
Percent change from baseline in corneal endothelial cell density at Week 24
Time Frame
Week 24
Title
Percentage of participants with adverse events of special interest (AESIs)
Time Frame
Up to Week 52
Title
Percent change from baseline in corneal endothelial cell density at Week 52
Time Frame
Week 52
Title
Aqueous humor (AH) concentration of RO7200200
Time Frame
Up to Week 52
Title
Serum concentration of RO7200220
Time Frame
Up to Week 52
Title
Anti-drug antibody titer to RO7200220
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol Diagnosis of macular edema associated with non-infectious uveitis (NIU) Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts Exclusion Criteria: Evidence of active or latent syphilis infection Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis Serious acute or chronic medical or psychiatric illness History of major ocular and non-ocular surgical procedures Uncontrolled IOP or glaucoma or chronic hypotony Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 Diagnosis of macular edema due to any cause other than NIU Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GR44277 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Retina Associates, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711-1141
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Valley Retina PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Name
Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Recruiting
Facility Name
Envision Ocular, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Individual Site Status
Recruiting
Facility Name
The Retina Consultants
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Health Eye Centre
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science Uni
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Erie Retinal Surgery
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt Eye Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Clinical Research LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Kapoor Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Alberta Retina Consultants
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 0X5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kensington Vision and Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Individual Site Status
Recruiting
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Jilin University; ophthalmology department
City
Changchun City
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital Zhejiang University College of Medicine; Ophthalmology
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin City
ZIP/Postal Code
300070
Country
China
Individual Site Status
Recruiting
Facility Name
Ren Min Hospital Affiliated Wu Han University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Opthalmology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah MC; Ophtalmology
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center; Ophtalmology
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin MC; Ophtalmology
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center; Ophtalmology
City
Rehovot
ZIP/Postal Code
7660101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky MC; Ophtalmology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
AUSL ? IRCCS Santa Maria Nuova; Immunologia Oculare
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Ospedale San Raffaele;U.O. Oculistica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Medical Center
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kim's Eye Hospital
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital de la Ceguera APEC
City
Mexico, D.F.
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Oftalmologia Monterrey - Vision100 (IOM)
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64630
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Het Oogziekenhuis Rotterdam
City
Rotterdam
ZIP/Postal Code
3011 BH
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
OFTALMIKA Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gabinet Okulistyczny Prof Edward Wylegala
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPEKTRUM Osrodek Okulistyki Klinicznej
City
Wroclaw
ZIP/Postal Code
53-334
Country
Poland
Individual Site Status
Recruiting
Facility Name
AIBILI - Association for Innovation and Biomedical Research on Light
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto de Oftalmologia Dr. Gama Pinto
City
Lisboa
ZIP/Postal Code
1169-019
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Santa Maria; Servico de Oftalmologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital; Ophthalmology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital; Ophthalmology
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Linkou; Ophthalmology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema

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