CTRI/2022/04/041823尚未招募2 期
TGF-BETa 2 antisense ISTH0036 for the Treatment of diabetic macular Edema (DME) and neovascular age-related maculaR degeneration (nAMD) as Monotherapy or in combination with Aflibercept The ââ?¬Å?BETTERââ?¬? Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •Patients eligible for inclusion in this study must meet all the following criteria:
- •1. Patients must provide written informed consent before any study related procedures are performed.
- •2. Patients must be ââ?°Â¥18 yrs in the DME cohort and ââ?°Â¥ 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 naÃ?¯ve nAMD arm.
- •4. About 50% of the patients in the AMD treatment naÃ?¯ve 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 ââ?°Â¥305 Ã?¼m in women, and ââ?°Â¥320Ã?¼m in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naÃ?¯ve nAMD arm.
- •7. For treatment naÃ?¯ve 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 naÃ?¯ve and VEGF primed group: Treatment naÃ?¯ve nAMD in study eye
- •9. For VR-group: Dry or ââ?°Â¤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 naÃ?¯ve DME.
- •11. Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening with CMT ââ?°Â¥305 Ã?¼m in women, and ââ?°Â¥320Ã?¼m in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naÃ?¯ve DME arm.
- •12. For treatment naÃ?¯ve 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 naÃ?¯ve group: Treatment naÃ?¯ve 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 ââ?°Â¥20% reduction in CMT secondary to diabetes after receiving 1-6 monthly anti-VEGF injections over the last 9 months.
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion in this study.
- •Ocular conditions
- •1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline.
- •2. Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening (except when due to conditions whose surgery may improve visual acuity, e.g., cataract).
- •Study eye nAMD
- •3. nAMD diagnosed for more than 9 months
- •4. Poor quality of SD-OCT images at Screening or Baseline.
- •5. Central subfield of the study eye affected by geographic atrophy assessed by OCT, color fundus photography (CFP) and fundus autofluorescence (FAF) at Screening.
- •6. Subretinal blood affecting the central subfield and/or ââ?°Â¥ 50% of the lesion of the study eye at Screening.
- •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 Screening that in the investigatorââ?¬•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 Baseline.
- •10. Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the investigatorââ?¬•s judgment at Screening or Baseline.
- •11. Aphakia and/or complete absence of the posterior capsule in the study eye at Screening.
- •12. For Treatment naÃ?¯ve 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 months
- •14. For VR-group: > 6 anti-VEGF injections
- •Study eye DME
- •15. Treatment requiring DME diagnosed for more than 9 months
- •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 Screening that in the investigatorââ?¬•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 to Baseline.
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