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)

Use our guide to learn which trials are right for you!

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
sites
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Bloomfield, New Jersey 07003
?
mi
from
Bloomfield, NJ
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
725 Uruguay
Buenos Aires, C1015ABO
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
1300 Jefferson Park Avenue
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
1606 Gunbarrel Road
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
8 Ranoldo Terrace
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2770 North Union Boulevard
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Encino, California 91436
?
mi
from
Encino, CA
Click here to add this to my saved trials
Florence, South Carolina 29501
?
mi
from
Florence, SC
Click here to add this to my saved trials
1224 Graham Road
Florissant, Missouri 63031
?
mi
from
Florissant, MO
Click here to add this to my saved trials
Fort Lauderdale, Florida 33334
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33912
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Grand Rapids, Michigan 45946
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49525
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
2321 Ira East Woods Avenue
Grapevine, Texas 76051
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
7021 Augusta Road
Greenville, South Carolina 29604
?
mi
from
Greenville, SC
Click here to add this to my saved trials
200 Motor Parkway
Hauppauge, New York 11788
?
mi
from
Hauppauge, NY
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
9551 U.S. 78
Ladson, South Carolina 29456
?
mi
from
Ladson, SC
Click here to add this to my saved trials
Las Vegas, Nevada
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
16 Hayden Avenue
Lexington, Kentucky 02421
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90333
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
502 East New Haven Avenue
Melbourne, Florida 32901
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Mountain View, California 94040
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Oak Forest, IL
Click here to add this to my saved trials
Palm Beach Gardens, Florida 33418
?
mi
from
Palm Beach Gardens, FL
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85014
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85020
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
3303 Southwest Bond Avenue
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
160 Sawgrass Drive
Rochester, New York 14620
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
4344 Central Avenue North
Saint Petersburg, Florida 33711
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Barbara, California 93103
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
9800 Levin Road Northwest
Silverdale, Washington 98383
?
mi
from
Silverdale, WA
Click here to add this to my saved trials
SLingerlands, New York 12159
?
mi
from
SLingerlands, NY
Click here to add this to my saved trials
601 Maple Drive
Springdale, Arkansas 72764
?
mi
from
Springdale, AR
Click here to add this to my saved trials
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Walnut Creek, California 94598
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Waterford, Connecticut 06385
?
mi
from
Waterford, CT
Click here to add this to my saved trials
Wichita, Kansas 67226
?
mi
from
Wichita, KS
Click here to add this to my saved trials