EUCTR2020-001174-30-HR进行中（未招募）1 期
AN EXPLORATORY, PROSPECTIVE,MULTI-CENTER, OPEN-LABEL, SINGLE-ARM,INTERVENTIONAL, PHASE IIB STUDY TOINVESTIGATE AQUEOUS HUMOR ANDMULTIMODAL IMAGING BIOMARKERS INTREATMENT-NAÏVE PATIENTS WITH DIABETICMACULAR EDEMA TREATED WITH FARICIMAB(RO6867461) - ALTIMETER STUDY - ALIMETER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed Consent
- •1. Signed ICF prior to any study-related assessments
- •o All patients are able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonisation (ICH) and local regulations.
- •o Patients are willing to allow AH collection and in the opinion of the Investigator, sampling of >90 µl of AH seems feasible and safe.
- •2. Ability to comply with the study protocol, in the Investigator’s judgment
- •3. Age =18 years at the time of signing the ICF
- •Type of DME Patients and Disease Characteristics
- •4. Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association and
- •o Current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) for the treatment of diabetes
- •o Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
- •5. Hemoglobin A1c (HbA1c) =10% (historic values up to 2 months before the screening visit will be permissible; otherwise, the study site may collect a sample for analysis at screening)
- •6. Patients who are IVT treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye).
- •Ocular Inclusion Criteria for Study Eye
- •7. Diabetic macular edema (DME) defined as macular thickening by spectral-domain optical coherence tomography (SD-OCT) involving the center of the macula: CST of =325 µm with Spectralis® (Heidelberg Engineering, Heidelberg, Germany) at screening. This inclusion criterion is to be assessed by the central reading center (CRC).
- •8. Moderately severe to severe non-proliferative DR (NPDR) (defined as any ETDRS DRSS from 47A through 53E [Ip et al. 2012]) or mild or moderate proliferative DR (PDR) (defined as ETDRS DRSS 60 through 65C [Ip et al. 2012]). This inclusion criterion is to be assessed by the CRC.
- •9. Decreased VA attributable primarily to DME, with BCVA letter score of 75 to 20 letters (both inclusive) on ETDRS-like charts at the screening visit
- •10. Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
- •Contraception
- •11. For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
- •o Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of faricimab.
- •o A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the Investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- •o Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •o Contraception methods that do not result in a failure rate of <1% per year such as male or female condom with or without spermicide; and
排除标准
- •Medical Conditions
- •Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
- •Any known hypersensitivity to any of the components in the faricimab injection, dilating eye drops, or any of the anesthetics and antimicrobial preparations used by the patient during the study
- •Any major illness or major surgical procedure within 1 month before the Day 1. One re-screening for this criterion is permitted
- •History of other diseases, 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 study or renders the patient at high-risk for treatment complications, in the opinion of the Investigator
- •Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of =6 and a stable prostate-specific antigen for >12 months
- •Stroke or myocardial infarction within 12 months prior to the Day 1. One re-screening for this criterion is permitted
- •Any febrile illness within 1 week prior to Day 1. One re-screening for this criterion is permitted
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
- •WOCBP must have a negative serum pregnancy test result within 28 days prior to initiation of faricimab and a negative urine pregnancy test at the baseline visit
- •Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
- •Any condition resulting in a compromised immune system that is likely to impact the AH inflammatory biomarkers. In case of doubt, the Investigator should consult with the Medical Monitor
- •Prior/Concomitant Therapy
- •Patients who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within 3 months or 5 half-lives prior to Day 1 and up to completion of the current study
- •Substance abuse occurring within 12 months prior to screening, in the Investigator's judgment
- •Use of systemic immunomodulatory treatments within 6 months or 5 half-lives prior to Day 1, systemic corticosteroids within 1 month prior to Day 1
- •Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives prior to Day 1
- •Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-month period or 5 half-lives prior to Day 1 or likely need to be used
- •Received a blood transfusion within 3 months prior to the screening visit, received any treatment that leads to immunosuppression within 6 months or 5 half-lives prior to Day 1
- •Ocular Exclusion Criteria for Study Eye
- •Mild or moderate NPDR. This exclusion criterion is to be assessed by the CRC
- •Any history of or ongoing rubeosis iridis
- •Any panretinal photocoagulation or macular laser photocoagulation treatment received in the study eye prior to the screening visit or expected to be received between the screening visit and Day 1
- •Any history of treatment with anti-VEGF or any
研究者
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