Diabetic macular edema Diabetic Macular Edema
Conditions
Interventions
This is an open-label, single-arm, interventional, multicenter trial to evaluate the efficacy and safety of a new dosing regimen of faricimab adapted to clinical practice in patients with DME. This tr
Faricimab, Visit control
Sponsors
Toshinori Murata
Omoto Takashi
Tsujimura Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1 Patients who provide written informed consent 2 Age >- 18 at the time of consent 3 Confirmed diagnosis of diabetes mellitus (Type 1 or Type 2) 4 Ability and willingness to undertake all scheduled visits and assessments Inclusion Criteria for Study Eye One eye will be designated as a study eye. If both eyes are determined to be eligible, the eye with the worse BCVA at screening will be selected as a study eye, unless the investigator or co-investigator determines that the other eye is more appropriate for research treatment. 1 Macular thickening secondary to DME involving the center of the fovea with CST >- 325 micrometre, as measured on Spectralis SD-OCT, or >- 315 micrometre, as measured on Cirrus SD OCT or Topcon SD-OCT (or other equivalent OCTs) at screening 2 BCVA of 0.0625 ~ 0.7 (decimal visual acuity) on visual acuity test at screening 3 Sufficiently clear optic media and adequate pupillary dilatation to allow acquisition of good quality color fundus photography (CFP) and other imaging modalities
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1 History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to faricimab and any of its excipients, mydriatic eye drops, anesthetics or antimicrobials 2 History of other disease, other non-diabetic metabolic dysfunction, physical examination finding, historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the trial or renders the patient at high risk for treatment complications in the opinion of the investigator or co-investigator 3 Active cancer within the past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of 12 months 4 Systemic treatment for suspected or active systemic infection 5 Participation in an investigational study that involves treatment with any drug or device (except for vitamins and minerals) within 3 months prior to Day 1 6 Administration of systemic pro-angiogenic treatments for the peripheral or coronary ischemia (e.g., limb ischemia or myocardial infarction) within 3 months prior to Day 1 7 Not willing to comply with the trial or follow-up procedures 8 Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial 9 Uncontrolled blood pressure (defined as systolic >180 mmHg and/or diastolic >100 mmHg while a patient is at rest). If a patients initial reading exceeds these values, a second reading may be obtained later the same day or on another day during the screening period. 10 Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1 11 Pregnancy or breastfeeding, or intention to become pregnant during the trial 12 Women of childbearing potential I) who does not agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of -1/2 disc area within an area equivalent to the mydriatic ETDRS 7 fields on clinical examination or CFPs 3) Neovascularization at disc >-1/3 disc area on clinical examination 2 Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction syndrome, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye 3 Active rubeosis 4 Uncontrolled glaucoma 5 History of retinal detachment or macular hole (Stage 3 or 4) 6 Aphakia or implantation of anterior chamber intraocular lens 7 Intravitreal administration of anti-VEGF agents within 3 months prior to Day 1 (applicable to patients whose study eyes were previously treated with intravitreal anti-VEGF agents), or any intravitreal administration of anti-VEGF agents to study eye prior to Day 1 (applicable for treatment-naive patients) Enrollment of patients w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) at 1 year I). The BCVA is measured as decimal visual acuity and converted to logarithm of the minimum angle of resolution (logMAR) values to calculate the changes in BCVA. I) 1 year means the average of Weeks 52, 56, and 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in BCVA at a visit proximate to the last dose among W52, W56, and W60 II) (logMAR). II) i.e., W56 and W60, respectively, if the last dose occurs at W52 or W56. Otherwise, W52. - Change from baseline in central subfield thickness (CST) at 1 year. The following items at each time points - BCVA and change from baseline in BCVA (logMAR) - Proportion of patients with a > logMAR 0.3 improvement from baseline in BCVA - Proportion of patients without a > logMAR 0.3 worsening from baseline in BCVA - Proportion of patients with BCVA (decimal visual acuity) > 0.5 - Proportion of patients with BCVA (decimal visual acuity) > 0.7 - Proportion of patients with BCVA (decimal visual acuity) > 1.0 - Proportion of patients with BCVA (decimal visual acuity) 2-step diabetic retinopathy severity (DRS) improvement from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) - Proportion of patients with a > 3-step DRS improvement from baseline on the ETDRS DRSS - Proportion of patients who develop new PDR - Proportion of patients who develop new neovascular glaucoma - Proportion of patients by treatment intervals - Average number of dosing of faricimab - The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score and its change from baseline | — |
Contacts
Public ContactTakao Hirano
Shinshu University Hospital
Outcome results
None listed