NCT04853251招募中4 期
A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 127
- 主要终点
- Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy
研究概览
简要总结
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The BVCA examiner will be masked as best as possible to participant study eye assignment and study visit type.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular Inclusion Criteria:
- •Diagnosis of nAMD prior to screening as determined by the investigator
- •Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
- •Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
- •Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
- •Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
- •Overall decrease in nAMD disease activity detected on historical or screening OCT
- •Stable or improved best-corrected visual acuity (BCVA)
- •BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
- •All subtypes of nAMD lesions are permissible
- •nAMD lesions at the time of diagnosis must involve the macula
- •Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images
排除标准
- •Prior Ocular Treatment
- •Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
- •Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
- •Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
- •History of corneal transplant
- •History of conjunctival surgery in the superotemporal quadrant
- •History of intraocular inflammation following anti-VEGF injection
- •Either Eye:
- •Previous PDS implantation
- •Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
- •Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
- •Prior pars plana vitrectomy surgery
- •Previous intraocular device implantation, excluding intraocular lenses
- •History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
- •Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening
- •Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
- •Contact lens wear in either eye within 2 months of screening
- •Any prior penetrating ocular trauma
- •Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening
- •History of corneal transplantation, including partial-thickness corneal grafts
- •Prior treatment with brolucizumab
- •Prior treatment with external-beam radiation therapy or brachytherapy
- •History of hypersensitivity to ranibizumab or any excipients of Susvimo
- •Macular Neovascularization Lesion (MNV) Characteristics
- •Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area [1.27 square millimeters (mm^2)] in size
- •Subfoveal fibrosis or subfoveal atrophy
- •Either Eye:
- •MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- •MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)
- •Current or Historical Ocular Conditions
- •Retinal pigment epithelial tear
- •Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
- •Current vitreous hemorrhage
- •Current or history of retinal detachment
- •Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
- •Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination
- •Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
- •Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
- •Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery
- •Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
- •Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
- •Conjunctival pathologies in the superotemporal quadrant
- •History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
- •Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
- •Trichiasis
- •Corneal neuropathy
- •Lagophthalmos or incomplete blink
- •Active or history of facial nerve palsy/paresis
- •Fellow (Non-Study) Eye:
- •Concurrent or history of PDS implantation
- 另有 36 项未显示
研究组 & 干预措施
SUSVIMO
Experimental
Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres [uL] of the 100 milligrams/millilitres [mg/ml] formulation of ranibizumab [approximately 2 milligrams (mg) dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
干预措施: LUCENTIS (Ranibizumab Injection) (Drug)
SUSVIMO
Experimental
Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres [uL] of the 100 milligrams/millilitres [mg/ml] formulation of ranibizumab [approximately 2 milligrams (mg) dose of ranibizumab]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
干预措施: PDS Implant With Ranibizumab 100 mg/ml (Device)
结局指标
主要结局
Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy
时间窗: Baseline, Week 48
次要结局
- Duration of Ocular AESIs(Day 1 to Week 52)
- Percentage of Participants With Ocular AESIs During the Postoperative Period(Baseline up to 37 days of initial implantation)
- Percentage of Participants With Ocular AESIs During the Intermediate Postoperative Period(38 to 93 days after implantation)
- Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye(Baseline, Week 24)
- Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye(Baseline, Week 24, Week 48)
- Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye(Baseline, Week 24, Week 48)
- Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs(Day 1 up to approximately Week 52)
- Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs(Day 1 to Week 52)
- Percentage of Participants With Ocular AESIs During the Follow-up Period(Week 52)
- Percentage of Participants With Adverse Device Effects (ADEs)(Day 1 to Week 52)
- Number of Participants with Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs(Day 1 to Week 52)
- Duration of ASADEs(Day 1 to Week 52)
研究者
研究点 (127)
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