A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:October 9, 2018
End Date:July 1, 2022
Contact:Reference Study ID Number: GR40398 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (RHINE)

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation, compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Inclusion Criteria:

- Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to
(≤) 10%

- Macular thickening secondary to diabetic macular edema (DME) involving the center of
the fovea

- Decreased visual acuity attributable primarily to DME

- Ability and willingness to undertake all scheduled visits and assessments

- For women of childbearing potential: agreement to remain abstinent or use acceptable
contraceptive methods that result in a failure rate of <1% per year during the
treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

- Currently untreated diabetes mellitus or previously untreated patients who initiated
oral anti-diabetic medication or insulin within 3 months prior to Day 1

- 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

- Treatment with panretinal photocoagulation or macular laser within 3 months prior to
Day 1 to the study eye

- Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1
to the study eye

- Prior administration of IVT faricimab in either eye

- 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
We found this trial at
61
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Augusta, Georgia 30909
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Austin, Texas 78705
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Bakersfield, California 93309
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Beverly Hills, California 90211
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Bloomfield, New Jersey 07003
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Boston, Massachusetts 02111
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Boston, MA
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725 Uruguay
Buenos Aires, C1015ABO
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Buenos Aires,
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
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Charlottesville, VA
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1606 Gunbarrel Road
Chattanooga, Tennessee 37421
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8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
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Chicago, IL
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2770 North Union Boulevard
Colorado Springs, Colorado 80909
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Encino, California 91436
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Encino, CA
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Florence, South Carolina 29501
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Florence, SC
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1224 Graham Road
Florissant, Missouri 63031
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Fort Lauderdale, Florida 33334
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Fort Myers, Florida 33912
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Fullerton, California 92835
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Grand Rapids, Michigan 45946
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Grand Rapids, Michigan 49525
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2321 Ira East Woods Avenue
Grapevine, Texas 76051
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7021 Augusta Road
Greenville, South Carolina 29604
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200 Motor Parkway
Hauppauge, New York 11788
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Houston, Texas 77030
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Knoxville, Tennessee 37909
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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9551 U.S. 78
Ladson, South Carolina 29456
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Las Vegas, Nevada
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16 Hayden Avenue
Lexington, Kentucky 02421
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Los Angeles, California 90033
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Los Angeles, California 90333
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502 East New Haven Avenue
Melbourne, Florida 32901
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Mountain View, California 94040
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Nashville, Tennessee 37203
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Palm Beach Gardens, Florida 33418
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Pasadena, California 91105
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85014
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Phoenix, Arizona 85020
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Plantation, Florida 33324
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Richmond, Virginia
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160 Sawgrass Drive
Rochester, New York 14620
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Rockville Centre, New York 11570
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Sacramento, California 95819
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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Salt Lake City, Utah 84107
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Santa Barbara, California 93103
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9800 Levin Road Northwest
Silverdale, Washington 98383
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SLingerlands, New York 12159
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601 Maple Drive
Springdale, Arkansas 72764
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Towson, Maryland 21204
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Walnut Creek, California 94598
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Waterford, Connecticut 06385
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Wichita, Kansas 67226
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