Back to resultsA Study to Investigate RO7200220 in Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RO7200220
Ranibizumab
Sham Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Willingness to allow Aqueous Humor collection
- For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
Exclusion Criteria:
- Hemoglobin A1c (HbA1c) of greater than (>) 12%
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Prior treatment with panretinal photocoagulation or macular laser to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
- Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
- Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
- Prior administration of IVT brolucizumab (Beovu®): ever; RO7200220: </=24 weeks prior to Day 1) in either eye
- Any proliferative diabetic retinopathy
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- 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 DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Sites / Locations
- Win RetinaRecruiting
- Retina-Vitreous Associates Medical GroupRecruiting
- Retina Consultants, San DiegoRecruiting
- Retinal Consultants Med GroupRecruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterRecruiting
- Bay Area Retina AssociatesRecruiting
- Colorado Retina Associates, PCRecruiting
- Emerson Clinical Research Institute LLCRecruiting
- Rand EyeRecruiting
- Pinnacle Research Institute
- National Ophthalmic Research InstituteRecruiting
- Retina Macula Specialists of Miami - LeJeune Road Office
- Florida Retina InstituteRecruiting
- Retina Vitreous Associates of FloridaRecruiting
- Retina Specialists of TampaRecruiting
- Butchertown Clinical TrialsRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Tallman Eye AssociatesRecruiting
- Deep Blue Retina PLLCRecruiting
- Sierra Eye AssociatesRecruiting
- Opthalmic Consultants of LIRecruiting
- Buffalo Niagara Retina Associates
- Retina Associates of Western New YorkRecruiting
- Western Carolina Retinal Associate PARecruiting
- Wake Forest University Health SciencesRecruiting
- Meridian Clinical ResearchRecruiting
- Cleveland Clinic FoundationRecruiting
- Verum Research LLCRecruiting
- EyeHealth NorthwestRecruiting
- Erie Retinal SurgeryRecruiting
- Eye Care Specialists, PCRecruiting
- Sewickley Eye GroupRecruiting
- Charleston Neuroscience InstituteRecruiting
- Black Hills Eye InstituteRecruiting
- Retina Consultants of NashvilleRecruiting
- Texas Retina AssociatesRecruiting
- Austin Clinical Research LLCRecruiting
- Valley Retina Institute P.A.Recruiting
- Medical Center Ophthalmology AssociatesRecruiting
- Retina Consultants of TexasRecruiting
- Strategic Clinical Research Group, LLCRecruiting
- Piedmont Eye CenterRecruiting
- Wagner Kapoor InstituteRecruiting
- Centro Oftalmológico Dr. Charles S.A.
- Oftalmos
- Buenos Aires MáculaRecruiting
- Centro Privado de Ojos RomagosaRecruiting
- Centro de ojos Loria
- OftarRecruiting
- Microcirugía Ocular S.ARecruiting
- Grupo Laser VisionRecruiting
- Organizacion Medica de InvestigacionRecruiting
- The Retina Centre of Ottawa
- Toronto Retina Institute
- Institut De L'Oeil Des Laurentides
- Faculty Hospital Ostrava; Ophthalmology clinic
- Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
- General Teaching Hospital Prague; Ophthalmology clinic
- AXON Clinical
- Pusan National University HospitalRecruiting
- Yeungnam University Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Kim's Eye HospitalRecruiting
- Centrum Medyczne Julianow
- Dobry Wzrok Sp Z O O
- Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
- Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
- Centrum Medyczne UNO-MED
- SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
- Centrum Diagnostyki i Mikrochirurgii Oka LENS
- LensClinicRecruiting
- Caminomed
- Emanuelli Research and Development Center LLCRecruiting
- Hospital General de Catalunya; Servicio de oftalmologia
- Hospital Universitario Puerta de Hierro; Servicio de oftalmologia
- Oftalvist Valencia
- Hospital Universitario Miguel Servet; Servicio de Oftalmologia
- Bradford Royal InfirmaryRecruiting
- Bristol Eye HospitalRecruiting
- Gloucestershire Hospitals NHS Foundation TrustRecruiting
- Royal Surrey County Hospital
- Moorfields Eye Hospital NHS Foundation TrustRecruiting
- Royal Victoria InfirmaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Arm A: 0.25 mg RO7200220 Q8W
Arm B: 1.0 mg RO7200220 Q8W
Arm C: 1.0 mg RO7200220 Q4W
Arm D: 0.5 mg Ranibizumab Q4W
Arm Description
Participants will receive RO7200220 0.25 milligrams (mg), by Intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.
Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Secondary Outcome Measures
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
Number of Participants With Abnormalities in Standard Ophthalmological Assessments
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Change From Baseline in BCVA Over Time
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time
Change From Baseline in Central Subfield Thickness (CST) at Week 48
Change From Baseline in CST at Week 36
Change From Baseline in CST at Week 24
Change From Baseline in CST Over Time
Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time
Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05151731
Brief Title
A Study to Investigate RO7200220 in Diabetic Macular Edema
Official Title
A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
October 3, 2024 (Anticipated)
Study Completion Date
April 17, 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
5. Study Description
Brief Summary
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: 0.25 mg RO7200220 Q8W
Arm Type
Experimental
Arm Description
Participants will receive RO7200220 0.25 milligrams (mg), by Intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Arm Title
Arm B: 1.0 mg RO7200220 Q8W
Arm Type
Experimental
Arm Description
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.
Arm Title
Arm C: 1.0 mg RO7200220 Q4W
Arm Type
Experimental
Arm Description
Participants will receive RO7200220 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.
Arm Title
Arm D: 0.5 mg Ranibizumab Q4W
Arm Type
Active Comparator
Arm Description
Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.
Intervention Type
Drug
Intervention Name(s)
RO7200220
Intervention Description
RO7200220 will be administered by IVT injection as specified in each treatment arm.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Time Frame
Baseline, Week 44 and Week 48
Secondary Outcome Measure Information:
Title
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Time Frame
Up to Week 72
Title
Number of Participants With Abnormal Laboratory Findings, Abnormal Vital Signs Values, or Abnormal Electrocardiogram (ECG) Parameters
Time Frame
Up to Week 72
Title
Number of Participants With Abnormalities in Standard Ophthalmological Assessments
Time Frame
Up to Week 72
Title
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Time Frame
Baseline, Week 44 and Week 48
Title
Mean Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Time Frame
Baseline, Week 44 and Week 48
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Time Frame
Baseline, Week 20 and Week 24
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Time Frame
Baseline, Week 32 and Week 36
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Time Frame
Baseline, Week 32 and Week 36
Title
Mean Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Time Frame
Baseline, Week 32 and Week 36
Title
Change From Baseline in BCVA Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent), or ≥ 84 Letters (20/20 Snellen Equivalent) Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Change From Baseline in Central Subfield Thickness (CST) at Week 48
Time Frame
Baseline, Week 48
Title
Change From Baseline in CST at Week 36
Time Frame
Baseline, Week 36
Title
Change From Baseline in CST at Week 24
Time Frame
Baseline, Week 24
Title
Change From Baseline in CST Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants With Absence of Diabetic Macular Edema (DME) Over Time
Time Frame
From baseline up to end of study (up to Week 72)
Title
Percentage of Participants With Absence of Intraretinal Fluid and/or Subretinal Fluid Over Time
Time Frame
From baseline up to end of study (up to Week 72)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetes mellitus (Type 1 or Type 2)
Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
Decreased visual acuity attributable primarily to DME
Ability and willingness to provide written informed consent and to comply with the study protocol
Willingness to allow Aqueous Humor collection
For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
Exclusion Criteria:
Hemoglobin A1c (HbA1c) of greater than (>) 12%
Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Prior treatment with panretinal photocoagulation or macular laser to the study eye
Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
Prior administration of IVT brolucizumab (Beovu®): ever; RO7200220: </=24 weeks prior to Day 1) in either eye
Any proliferative diabetic retinopathy
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
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 DME in the study eye
Other protocol-specified inclusion/exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BP43445 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
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
Win Retina
City
Arcadia
State/Province
California
ZIP/Postal Code
91006
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants, San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
Recruiting
Facility Name
Emerson Clinical Research Institute LLC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011-3010
Country
United States
Individual Site Status
Recruiting
Facility Name
Rand Eye
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Individual Site Status
Completed
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Macula Specialists of Miami - LeJeune Road Office
City
Miami
State/Province
Florida
ZIP/Postal Code
33126-5690
Country
United States
Individual Site Status
Completed
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1101
Country
United States
Individual Site Status
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
Retina Specialists of Tampa
City
Wesley Chapel
State/Province
Florida
ZIP/Postal Code
33544
Country
United States
Individual Site Status
Recruiting
Facility Name
Butchertown Clinical Trials
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Individual Site Status
Recruiting
Facility Name
Tallman Eye Associates
City
Lawrence
State/Province
Massachusetts
ZIP/Postal Code
01843
Country
United States
Individual Site Status
Recruiting
Facility Name
Deep Blue Retina PLLC
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Opthalmic Consultants of LI
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Individual Site Status
Recruiting
Facility Name
Buffalo Niagara Retina Associates
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Individual Site Status
Completed
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Individual Site Status
Recruiting
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44915
Country
United States
Individual Site Status
Recruiting
Facility Name
Verum Research LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
EyeHealth Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
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
Eye Care Specialists, PC
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Individual Site Status
Recruiting
Facility Name
Sewickley Eye Group
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
Individual Site Status
Recruiting
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Individual Site Status
Recruiting
Facility Name
Black Hills Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
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
Valley Retina Institute P.A.
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
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
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
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
Centro Oftalmológico Dr. Charles S.A.
City
Capital Federal
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Buenos Aires Mácula
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1061AAE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Privado de Ojos Romagosa
City
Cordoba
ZIP/Postal Code
X5200ANS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de ojos Loria
City
Lomas de Zamora
ZIP/Postal Code
B1888FRB
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Oftar
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Microcirugía Ocular S.A
City
Rosario
ZIP/Postal Code
S2000CTC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Grupo Laser Vision
City
Rosario
ZIP/Postal Code
S2000DLA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
The Retina Centre of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Toronto Retina Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3C 0G9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 0E8
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Faculty Hospital Ostrava; Ophthalmology clinic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
General Teaching Hospital Prague; Ophthalmology clinic
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
AXON Clinical
City
Prague
Country
Czechia
Individual Site Status
Active, not 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
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
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
Kim's Eye Hospital
City
Seoul
ZIP/Postal Code
07301
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Julianow
City
?ód?
ZIP/Postal Code
91-321
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Dobry Wzrok Sp Z O O
City
Gda?sk
ZIP/Postal Code
80-402
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
City
Katowice
ZIP/Postal Code
40-514
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Medyczne UNO-MED
City
Krakow
ZIP/Postal Code
31-070
Country
Poland
Individual Site Status
Active, not 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
Active, not recruiting
Facility Name
Centrum Diagnostyki i Mikrochirurgii Oka LENS
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
LensClinic
City
Rybnik
ZIP/Postal Code
44-203
Country
Poland
Individual Site Status
Recruiting
Facility Name
Caminomed
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Emanuelli Research and Development Center LLC
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Hospital General de Catalunya; Servicio de oftalmologia
City
Sant Cugat De Valles
State/Province
Barcelona
ZIP/Postal Code
08190
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de oftalmologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Oftalvist Valencia
City
Burjassot
State/Province
Valencia
ZIP/Postal Code
46100
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Miguel Servet; Servicio de Oftalmologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
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
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS1 2LX
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
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
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 Diabetic Macular Edema
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