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RO7200220 in Participants With Uveitic Macular Edema (Sandcat)

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

  • Barnet Dulaney Perkins Eye CenterRecruiting
  • Northern California Retina Vitreous AssociatesRecruiting
  • California Eye Specialists Medical group Inc.Recruiting
  • Retina Consultants of Southern CaliforniaRecruiting
  • Kaiser Permanente Riverside Medical CenterRecruiting
  • University of California, Davis, Eye CenterRecruiting
  • Retinal Consultants Med GroupRecruiting
  • Advanced ResearchRecruiting
  • Retina Group of FloridaRecruiting
  • University Retina and Macula Associates, PCRecruiting
  • University of Michigan, Kellogg Eye CenterRecruiting
  • Assoc Retinal Consultants PCRecruiting
  • Mid Atlantic RetinaRecruiting
  • Duke Eye CenterRecruiting
  • Cleveland Clinic Foundation; Cole Eye InstituteRecruiting
  • Retina Research Institute of TexasRecruiting
  • Retina Consultants of Texas; Katy Retina CenterRecruiting
  • Retina Consultants of TexasRecruiting
  • University of Wisconsin; Ophthalmology and Visual SciencesRecruiting
  • Centro Privado de OjosRecruiting
  • Buenos Aires MáculaRecruiting
  • Consultorios Medicos Oftalmológicos
  • Oftalmologia Global
  • Organizacion Medica de InvestigacionRecruiting
  • Sydney Eye HospitalRecruiting
  • Centre For Eye Research AustraliaRecruiting
  • Eye Surgery AssociatesRecruiting
  • Retina Specialists VictoriaRecruiting
  • The Lions Eye InstituteRecruiting
  • General Teaching Hospital Prague; Ophthalmology clinicRecruiting
  • CHU Nantes - Hôtel Dieu; OphthalmologyRecruiting
  • Hopital Lariboisiere; OphtalmologieRecruiting
  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; OphthalmologyRecruiting
  • Universitätsklinikum Freiburg, Klinik für AugenheilkundeRecruiting
  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für AugenheilkundeRecruiting
  • Universitätsklinik Heidelberg; AugenklinikRecruiting
  • Universitätsklinikum Köln; AugenklinikRecruiting
  • St. Franziskus HospitalRecruiting
  • Universitäts-Augenklinik TübingenRecruiting
  • Kyushu University HospitalRecruiting
  • Hiroshima University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Kobe University Hospital; Endocrine Internal MedicineRecruiting
  • Kagoshima University HospitalRecruiting
  • Yokohama City University Hospital
  • Japan Community Health care Organization Osaka HospitalRecruiting
  • National Defense Medical College HospitalRecruiting
  • Tokyo Medical and Dental University HospitalRecruiting
  • Kyorin University HospitalRecruiting
  • Nippon Medical School Tama Nagayama HospitalRecruiting
  • Yamaguchi University Hospital
  • National University Hospital; Ophthalmology DepartmentRecruiting
  • Hospital Universitari de Bellvitge; Servicio de OftalmologiaRecruiting
  • Fundacion Jimenez Diaz-UTE; Servicio OftalmologiaRecruiting
  • Hospital Universitario Miguel Servet; Servicio de OftalmologiaRecruiting
  • Inselspital Bern Ophthalmologische KlinikRecruiting
  • Vista Klinik Ophthalmologische KlinikRecruiting
  • Stadtspital Triemli Ophthalmologische KlinikRecruiting
  • Hacettepe University Medical Faculty; Department of OphthalmologyRecruiting
  • Istanbul University Cerrahpasa Faculty of Medicine
  • Ege Üniversitesi Tip Fakültesi

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
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)
Percent change from baseline in corneal endothelial cell density at Week 24
Percentage of participants with non-ocular AEs
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 10, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05642325
Brief Title
RO7200220 in Participants With Uveitic Macular Edema
Acronym
Sandcat
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
March 23, 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
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
Percent change from baseline in corneal endothelial cell density at Week 24
Time Frame
Week 24
Title
Percentage of participants with non-ocular AEs
Time Frame
Up to Week 52
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: GR44278 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-LaRoche
Official's Role
Study Director
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Name
California Eye Specialists Medical group Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Riverside Medical Center
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Davis, Eye Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Name
Assoc Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Atlantic Retina
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation; Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas; Katy Retina Center
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384-4167
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin; Ophthalmology and Visual Sciences
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro Privado de Ojos
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1033AAW
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Buenos Aires Mácula
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1061AAE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Consultorios Medicos Oftalmológicos
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426DQS
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Oftalmologia Global
City
Rosario
ZIP/Postal Code
S2000DSK
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Centre For Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Eye Surgery Associates
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Name
Retina Specialists Victoria
City
Rowville
State/Province
Victoria
ZIP/Postal Code
3178
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
General Teaching Hospital Prague; Ophthalmology clinic
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU Nantes - Hôtel Dieu; Ophthalmology
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Lariboisiere; Ophtalmologie
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinik Heidelberg; Augenklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Köln; Augenklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. Franziskus Hospital
City
Munster
ZIP/Postal Code
48145
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitäts-Augenklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe University Hospital; Endocrine Internal Medicine
City
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Hospital
City
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Japan Community Health care Organization Osaka Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Defense Medical College Hospital
City
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyorin University Hospital
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Tama Nagayama Hospital
City
Tokyo
ZIP/Postal Code
206-8512
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi University Hospital
City
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National University Hospital; Ophthalmology Department
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
City
Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundacion Jimenez Diaz-UTE; Servicio Oftalmologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Miguel Servet; Servicio de Oftalmologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inselspital Bern Ophthalmologische Klinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Vista Klinik Ophthalmologische Klinik
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Stadtspital Triemli Ophthalmologische Klinik
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty; Department of Ophthalmology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Ege Üniversitesi Tip Fakültesi
City
Lzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Active, not 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

RO7200220 in Participants With Uveitic Macular Edema

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