EUCTR2021-001213-36-AT进行中（未招募）1 期
TGF-BETa 2 antisense ISTH0036 for the Treatment of diabeticmacular Edema (DME) and neovascular age-related maculaRdegeneration (nAMD)The BETTER” Study - Better
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1.Patients must provide written informed consent before any study related procedures are performed
- •2.Patients must be =18 yrs in the DME cohort and = 50 in the nAMD cohort at Screening
- •Study eye nAMD:
- •3.Active CNV lesions secondary to nAMD (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at Screening in treatment naïve nAMD arm.
- •4.About 50% of the patients in the AMD treatment naïve group should have classic or predominantly classic CNV / Type II CNV or hemorrhage
- •5.Pretreated CNV lesions secondary to nAMD (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at Screening in pretreated nAMD. About 50% of the patients should be included with SHRM present on OCT despite anti-VEGF therapy or hemorrhage present at initial diagnosis/ therapy start
- •6. Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening with CMT =305 µm in women, and =320µm in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naïve nAMD arm
- •7.For treatment naïve patients, BCVA between 83 and 23 letters, inclusive, in the study eye at Screening and Baseline using early treatment diabetic retinopathy study (ETDRS) testing.
- •8.For Treatment naïve and VEGF primed group: Treatment naïve nAMD in study eye
- •9.For VR-group: Dry or =50 micrometer SRF in vertical extension after receiving 1-6 anti-VEGF injections. Diagnosis no longer than 9 months before Baseline
- •Study eye DME:
- •10.Active CME secondary to diabetes in the study eye at Screening in treatment naïve DME.
- •11.Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening with CMT =305 µm in women, and =320µm in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naïve DME arm.
- •12.For treatment naïve patients, BCVA between 83 and 23 letters, inclusive, in the study eye at Screening and Baseline using early treatment diabetic retinopathy study (ETDRS) testing.
- •13.Moderate to severe NPDRP assessed via ETDRS severity scale and mild PDRP (with 1 NVE) in study eye (diabetic retinopathy severity scale DRSS 43-61)
- •14.Absence of prior PRP treatment
- •15.For Treatment naïve group: Treatment naïve DME in study eye
- •16.For VR-group: History of CME secondary to diabetes in the study eye with complete resolution of IRF and/or SRF or a =20% reduction in CMT secondary to diabetes after receiving 1-6 monthly anti-VEGF injections over the last 9 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at BL
- •2.Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Scr (except when due to conditions whose surgery may improve visual acuity, e.g., cataract)
- •3.nAMD diagnosed for more than 9 mon
- •4.Poor quality of SD-OCT images at Scr or BL
- •5.Central subfield of the study eye affected by geographic atrophy assessed by OCT, color fundus photography (CFP) and fundus autofluorescence (FAF) at Scr
- •6.Subretinal blood affecting the central subfield and/or = 50% of the lesion of the study eye at Scr
- •7.Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the investigator, could require medical or surgical intervention during the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
- •8.Structural damage within 0.5-disc diameter of the center of the macula in the study eye, e.g., vitreomacular traction, epiretinal membrane, retinal pigment epithelium (RPE) rip/tear scar, laser burn, at the time of Scr that in the investigator’s opinion could preclude visual function improvement with treatment
- •9.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to BL
- •10.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the investigator’s judgment at Scr or BL
- •11.Aphakia and/or complete of the posterior capsule in the study eye at Scr
- •12.For Treatment naïve and VEGF primed group:Any prior treatment for nAMD in study eye
- •13.For VR-group: > 50 micrometer SRF in vertical extension after receiving 1-6 anti-VEGF injections over the last 9 mon
- •14.For VR-group: > 6 anti-VEGF injections
- •15.Treatment requiring DME diagnosed for more than 9 mon
- •16.Poor quality of SD-OCT images
- •17.Focal laser scars within the central 1 mm ETDRS subfield
- •18.Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than DME, that, in the judgment of the investigator, could require medical or surgical intervention during the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
- •19.Structural damage within 0.5-disc diameter of the center of the macula in the study eye, e.g., vitreomacular traction, epiretinal membrane, retinal pigment epithelium (RPE) rip/tear scar, laser burn, at the time of Scr that in the investigator’s opinion could preclude visual function improvement with treatment
- •20.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior BL
- •21.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the investigator’s judgment at Scr or BL
- •22.Moderate and severe PDRP requiring PRP in study eye
- •23.Prior PRP treatment in study eye
- •24.Aphakia and/or complete of the posterior capsule in the study eye at Scr
- •25.For Treatment naïve group: Any prior treatment for DME in study eye
- •26.For VR-group: <20% reduction in CMT after receiving 1-6 monthly anti-VEGF injections over the last 9 mon after diagnosis.
- •27.For VR-group: > 6 anti-VEGF inje
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