NCT05642312已完成3 期
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 77
- 主要终点
- Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
研究概览
简要总结
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
- •Diagnosis of macular edema associated with non-infectious uveitis (NIU)
- •Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
- •BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
排除标准
- •Evidence of active or latent syphilis infection
- •Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
- •Serious acute or chronic medical or psychiatric illness
- •History of major ocular and non-ocular surgical procedures
- •Uncontrolled IOP or glaucoma or chronic hypotony
- •Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
- •Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
- •Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
- •Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
- •Diagnosis of macular edema due to any cause other than NIU
- •Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
研究组 & 干预措施
Arm A
Experimental
Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
干预措施: Vamikibart (Drug)
Arm B
Experimental
Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
干预措施: Vamikibart (Drug)
Arm C
Sham Comparator
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
干预措施: Sham (Other)
结局指标
主要结局
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
时间窗: Week 16
次要结局
- Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52(Weeks 16 and 52)
- Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52(Weeks 16 and 52)
- Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52(Weeks 16 and 52)
- Type of rescue treatments received(Up to Week 52)
- Percentage of participants with non-ocular AEs(Up to Week 52)
- Percent change from baseline in corneal endothelial cell density at Week 52(Week 52)
- Serum concentration of vamikibart(Up to Week 52)
- Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20(Week 20)
- Change from baseline in central subfield thickness (CST) at Week 16(Week 16)
- Percentage of participants with ocular adverse events (AEs)(Up to Week 52)
- Number of rescue treatments received(Up to Week 52)
- Aqueous humor (AH) concentration of vamikibart(Up to Week 52)
- Change from baseline in BCVA at Week 16(Week 16)
- Change from Baseline in BCVA at Weeks 20 and 52(Weeks 20 and 52)
- Change from baseline in CST at Weeks 20 and 52(Weeks 20 and 52)
- Time to rescue treatment(Up to Week 52)
- Number of PRN injections received(Up to Week 52)
- Time to first PRN injection(Up to Week 52)
- Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52(Weeks 16 and 52)
- Anti-drug antibody titer to vamikibart(Baseline to Week 52)
- Percent change from baseline in corneal endothelial cell density at Week 24(Week 24)
- Percentage of participants with adverse events of special interest (AESIs)(Up to Week 52)
研究者
研究点 (77)
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