A clinical trial to compare faricimab with aflibercept in people with diabetic macular edema. (RHINE)
A Study to Evaluate the Efficacy and Safety of RO6867461 in Participants With Diabetic Macular Edema
- Eye Disorder
- Diabetic Macular Edema
Completed
- Aalborg
- aan
- Ankara
- Augusta
- Aurora
- Austin
- Bakersfield
- Barcelona
- bei-jing-shi
- Beijing
- Belfast
- Beverly Hills
- Binningen
- blagny-sur-vingeanne
- Bloomfield
- Boisbriand
- Boston
- Bradford
- Braga
- Bristol
- Budapest
- Buenos Aires
- Burjasot
- Bydgoszcz
- Calgary
- Camberley
- Canterbury
- Chang Wat Chiang Mai
- chang-chun-shi
- Charlottesville
- Chattanooga
- Cheboksary
- Cheng Du Shi
- chong-qing-shi
- Chongqing
- Cleveland
- Coimbra
- Colorado Springs
- Créteil
- czerwionka-leszczyny
- Dresden
- East Melbourne
- Firenze
- Fort Lauderdale
- Fort Myers
- Freiburg im Breisgau
- Fullerton
- Gdańsk
- Glostrup
- Gloucester
- Goiás
- Grand Rapids
- Great Yarmouth
- Greenville
- guang-zhou-shi
- Halifax
- Hauppauge
- Hlavní město Praha
- Homburg
- Hong Kong Island
- Irkutsk
- İstanbul
- Kazan
- Knoxville
- Kocaeli
- Kraków
- Krung Thep Maha Nakhon
- Královéhradecký kraj
- L'Hospitalet de Llobregat
- Ladson
- Las Vegas
- Leeds
- Lisboa
- Liverpool
- Lombardy
- London
- Los Angeles
- Lyon
- Madrid
- Magdeburg
- Manchester
- Melbourne
- Mendoza
- Montréal
- Mountain View
- München
- Nanjing
- Nashville
- Nedlands
- negrar-di-valpolicella
- New York
- Newcastle upon Tyne
- Novosibirsk
- Oak Forest
- Oceanside
- Ostrava
- Ottawa
- Oviedo
- Palm Beach Gardens
- Pamplona
- Paris
- Philadelphia
- Phoenix
- Pisa
- Plantation
- Porto Alegre
- Richmond
- Rochester
- Roma
- Rosario
- Roskilde
- Rowville
- Rzeszów
- Sacramento
- Saint-Cyr-sur-Loire
- Sant Cugat del Vallès
- Santa Barbara
- Santa Catarina
- Seongnam-si
- Seoul
- shang-hai-shi
- Silverdale
- Singapore
- Slingerlands
- sokolov-1
- Southampton
- Southlake
- Springdale
- Springfield
- St. Petersburg
- Strathfield
- Sunderland
- Sydney
- São Paulo
- Taipei City
- Taoyuan City
- Tarnowskie Góry
- The Woodlands
- tian-jin-shi
- Toronto
- Toulouse
- Towson
- Udine
- uxbridge
- Valladolid
- València
- Vancouver
- Walnut Creek
- Warszawa
- Waterford
- wen-zhou-shi
- west-columbia
- Westmead
- wu-xi-shi
- Würzburg
NCT03622593 2017-005105-12 GR40398
Trial Summary
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).
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
Eligibility Criteria
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
- 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
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication 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
For the latest version of this information please go to www.forpatients.roche.com