A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO EVALUATE THE EFFICACY, AND SAFETY OF FARICIMAB IN PATIENTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (AZUSA)
A STUDY TO EVALUATE EFFICACY AND SAFETY OF FARICIMAB WIT HNON-PROLIFERATIVE DIABETIC RETINOPATHY
Murata Toshinori
Shinshu University Hospital
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo
+81-120189706
clinical-trials@chugai-pharm.co.jp
Clinical trials information
Chugai Pharmaceutical Co., Ltd.
1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo
+81-120189706
clinical-trials@chugai-pharm.co.jp
Recruiting
June. 15, 2025
May. 26, 2025
78
Interventional
randomized controlled trial
double blind
no treatment control/standard of care control
parallel assignment
treatment purpose
General Inclusion Criteria
-Patients aged 18 years or older at the time of informed consent
-Patients who had a documented diagnosis of diabetes mellitus (type 1 or 2) according to the definition of the Japan Diabetes Society or the WHO criteria and who met both or either of the following criteria
-Use of insulin or other injectable drugs (dulaglutide, liraglutide, etc.) for diabetes on a regular basis for 3 months prior to Day 1
-Use of an oral hypoglycemic agent for the treatment of diabetes on a regular basis for 3 months prior to Day 1
-Females of childbearing potential: Patients must agree to be abstinent from heterosexual intercourse or to use a method of contraception with a failure rate of less than 1% per year during the active treatment period and for 3 months after the last dose of active treatment or rescue dose of 6 mg faricimab, and must agree to refrain from donating eggs during this period.
Study Eye Inclusion Criteria
-Moderate or severe NPDR (ETDRS-DRSS 47 or 53) as determined by the Investigator and confirmed by the central reading center at Screening.
-Patient must not have CI-DME(CST >= 325 mcm as measured by Spectralis SD-OCT or CST >= 315 mcm as measured by Cirrus SD-OCT or Topcon SS-OCT) as assessed by the Investigator and confirmed by the Central reading center at Screening.
-BCVA of 65 letters (Snellen visual acuity 20/50, decimal visual acuity 0.4) or better on the ETDRS visual acuity test assessed at a starting distance of 4 meters on Day 1 (refer to the Ophthalmology Examination Manual for details).
-Adequately clear optic media and fully dilated pupils for analysis and evaluation by the central reading center.
General Exclusion Criteria
-Patients who need to use prohibited concomitant therapies during the study period
-Patients with screening HbA1c > 12%, or patients with HbA1c =< 12% but with uncontrolled diabetes in the opinion of the investigator
-Uncontrolled blood pressure (Defined as resting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) at Day 1.
-History of any other ocular condition that could reasonably contraindicate the use of faricimab, that could confound the interpretation of the study results, or that could put the patient at increased risk of complications
-Women who are pregnant or breastfeeding, or intending to become pregnant during the study
-Patients with history of severe allergic or anaphylactic reactions to biologics or known hypersensitivity to faricimab ingredients, study procedures, dilating drops, anesthetics and antibiotics the patient will use during the study
-Participation in any clinical study using a drug (except vitamins and minerals) or device within 3 months prior to Day 1
Study Eye Exclusion Criteria
-Active rubeosis, traction retinal detachment, or epiretinal membrane
-Patients with prior Intravitreal Anti-VEGF Therapy
-Patients with prior intravitreal or periocular (sub-Tenon's) steroid therapy, panretinal photocoagulation (PRP), selective photocoagulation or macular laser photocoagulation.
-Patients undergoing vitreoretinal surgery
-History of intraocular surgery (including cataract surgery) or corneal transplant within 3 months prior to randomization
-Has undergone glaucoma filtration surgery, glaucoma tube shunt surgery, minimally invasive glaucoma surgery, or pars plana vitrectomy or has an intraocular lens in the anterior chamber (excluding posterior chamber intraocular lens implantation).
-Any posterior capsular defect other than YAG laser posterior capsulotomy defect associated with an aphakic eye or history of posterior chamber intraocular lens implantation
-Patients with refractive error consistent with myopia having a spherical equivalent power of > - 8 diopters. If the study eye has undergone refractive surgery or cataract surgery, patients with preoperative refractive error greater than - 8 diopters
-Any concurrent ocular disease (e.g., cataract, epiretinal membrane) which may require a surgical intervention during the study to prevent or treat the resulting potential vision loss
Exclusion Criteria in Both Eyes
-Patients with a history of uveitis (Idiopathic uveitis, drug-induced uveitis, autoimmune uveitis, etc.)
18age old over
No limit
Both
Non-Proliferative Diabetic Retinopathy
RO6867461: The study will consist of 4 IVT injections of faricimab 6 mg Q4W from Day 1 through Week 12. Participants will then receive IVT injections of the 6-mg dose of faricimab every 8 weeks (Q8W) until Week 44. After Week 44, participants will receive IVT injections of the 6-mg dose of faricimab every 16 weeks.
efficacy
-Proportion of study participants achieving >= 2-step improvement from baseline in ETDRS-DRSS at Week 48
safety, efficacy
The following endpoints at Week 96
-Proportion of participants with a >= 2-step improvement in ETDRS-DRSS
The following endpoints at Week 48 and Week 96
-Proportion of participants who had at least one sight-threatening complication (PDR or ASNV) or CI-DME*
-Proportion of participants receiving PRP laser, IVT anti-VEGF injection, or vitrectomy (With or without intraocular laser) as rescue therapy
-Change from baseline in BCVA (measured from a distance of 4 meters on the ETDRS chart)
-Change from baseline in CST (ILM-BM) over time, as measured by OCT
-Incidence and severity of ocular AEs
-Incidence and severity of non-ocular AEs
Chugai Pharmaceutical Co., Ltd.
Institutional Review Board of Hayashi Eye Hospital
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).
