ISRCTN15871371进行中（未招募）1 期
A phase Ib, multicenter, randomized, double masked, active comparator-controlled study to investigate the biological activity, safety, tolerability, pharmacokinetics and pharmacodynamics of RO7200394 in participants with macular edema secondary to central retinal vein occlusion
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/12/2023:
- •1. Aged =40 years at the time of signing the informed consent form (ICF)
- •2. Body mass index (BMI) of =40 kg/m2 at screening
- •3. Consent to AH collection
- •4. Ability to comply with the study protocol
- •Ocular inclusion criteria for study eye:
- •1. Treatment-naïve macular edema due to CRVO prior to Day 1 and confirmed by the Central Reading Center (CRC)
- •2. Decreased best corrected visual activity (BCVA) primarily due to CRVO
- •3. Macular thickening secondary to retinal vein occlusion (RVO) with central subfield thickness (CST) =300 µm at screening
- •4. Adequately clear ocular media and adequate pupillary dilation to allow the acquisition of good-quality retinal images
- •Previous inclusion criteria as of 25/09/2023:
- •1. Aged =40 years at the time of signing the informed consent form (ICF)
- •2. Body mass index (BMI) of =40 kilograms per metre square (kg/m^2) at screening
- •3. Consent to AH collection
- •4. Ability to comply with the study protocol
- •Ocular Inclusion Criteria for Study Eye:
- •1. Treatment-naïve macular edema due to CRVO with initial symptoms and diagnosis = 45 days prior to Day 1 and confirmed by the Central Reading Center (CRC).
- •2. Decreased best corrected visual activity (BCVA) primarily due to CRVO with early treatment diabetic retinopathy study (ETDRS) score of 80 to 20 letters (both inclusive) at screening.
- •3. Macular thickening secondary to retinal vein occlusion (RVO) with central subfield thickness (CST) = 325 micrometer (µm), as measured on Spectralis spectral domain optical coherence tomography (SD-OCT), or = 315 µm, as measured on Cirrus SD-OCT or Topcon SD-OCT, at screening.
- •4. Adequately clear ocular media and adequate pupillary dilation to allow the acquisition of good quality retinal images.
- •Previous inclusion criteria:
- •1. Aged =40 years at the time of signing the informed consent form (ICF)
- •2. Body mass index (BMI) of =40 kilograms per metre square (kg/m^2) at screening
- •3. Consent to AH collection
- •4. Ability to comply with the study protocol
- •Ocular Inclusion Criteria for Study Eye:
- •1. Treatment-naïve macular edema due to CRVO diagnosed = 45 days prior to Day 1 and confirmed by the Central Reading Center (CRC).
- •2. Decreased best corrected visual activity (BCVA) primarily due to CRVO with early treatment diabetic retinopathy study (ETDRS) score of 80 to 20 letters (both inclusive) at screening.
- •3. Macular thickening secondary to retinal vein occlusion (RVO) with central subfield thickness (CST) = 325 micrometer (µm), as measured on Spectralis spectral domain optical coherence tomography (SD-OCT), or = 315 µm, as measured on Cirrus SD-OCT or Topcon SD-OCT, at screening.
- •4. Adequately clear ocular media and adequate pupillary dilation to allow the acquisition of good quality retinal images.
排除标准
- •Current exclusion criteria as of 21/12/2023:
- •1. Any known hypersensitivity to fluorescein, any of the excipients of the drug(s) used, dilating eye drops, or any anesthetics and antimicrobial drops
- •2. Previous clinically significant adverse reactions to intraocular biologics (e.g., thromboembolic events, intraocular inflammation)
- •3. Use of any systemic (e.g., oral/intravenous/intraarticular) corticosteroids and/or chronic use of inhaled or topical steroids = 4 weeks prior to Day 1, or any such treatment planned for the duration of the study
- •4. History of idiopathic or autoimmune-associated uveitis in either eye
- •5. Active periocular, ocular, or intraocular inflammation or infection (including suspected) in either eye on Day 1
- •6. Any of the following infectious diseases: Positive test for human immunodeficiency virus (HIV), history of active hepatitis B and C, active syphilis, active tuberculosis, symptomatic herpes zoster =12 weeks prior to screening
- •7. Participation in a clinical study for a non-ocular disease =60 days prior to Day 1, or =5 half-lives between the last exposure to study treatment in the previous study and Day 1 for the present study (whichever period is longer)
- •8. Use of prior systemic anti-vascular endothelial growth factor (VEGF) treatment =24 weeks prior to Day 1, or any such treatment planned for the duration of the study
- •9. Prior use of anti-tumor necrosis factor drugs
- •Ocular exclusion criteria for study eye:
- •1. Increase of =15 letters in BCVA ETDRS score between screening and Day 1
- •2. Any current or history of ocular condition which, in the opinion of the Investigator, is currently causing or may contribute to irreversible vision loss due to a cause other than macular edema due to CRVO in the study eye
- •3. History of retinal detachment or macular hole (Stage 3 or 4)
- •4. Advanced or uncontrolled glaucoma or intraocular pressure [IOP] >25 mmHg despite treatment
- •5. Tractional retinal detachment, vitreomacular traction, full thickness macular hole or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye, as evaluated by the Investigator, and described in the CRC manual
- •6. Diagnosis of diabetic retinopathy (DR), DME, nAMD, geographic atrophy, and myopic choroidal neovascularization as assessed by the investigator
- •7. Active rubeosis, angle neovascularization, neovascular glaucoma, or neovascularization of the disc (NVD), or neovascularization elsewhere (NVE)
- •8. Any other intraocular surgery (e.g., pars plana vitrectomy, scleral buckle, glaucoma surgery, corneal transplant, or radiotherapy)
- •9. Any prior or current treatment for macular edema due to CRVO e.g., laser or pharmacological
- •10. Panretinal photocoagulation in the study eye at any time prior to Day 1 or anticipated =2 weeks of study start on Day 1
- •11. Any prior or current treatment with e.g., tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
- •12. Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
- •13. Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex®) and fluocinolone acetonide intravitreal implant (Iluvien)
- •14. Prior periocular pharmacological or IVT treatment for other retinal diseases
- •15. Any active intra- or periocular infection on Day 1
- •16. Active intraocular inflammation (i.e., Standardization of Uveitis Nomenclature [SUN] criteria >0 or NEI vitreous haze grad
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