Conbercept in Choroidal Neovascularization Secondary to Uveitis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit
研究概览
简要总结
The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept.
This will be a randomized, placebo-controlled trial. 20 patients will receive three injections of Conbercept into the affected eye (and repeated injections if required), and 20 patients will receive three sham injections requiring no needle stick, but making the patient unaware of whether or not he received active treatment.
Outcome of the two treatment groups will be compared after one year.
详细描述
Primary Outcome Measures: Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]
Secondary Outcome Measures: Mean change from baseline in retinal thickness [ Time Frame: 12 months ]
Mean number of Conbercept injections required over 12 months [ Time Frame: 12 months ]
Ocular and systemic adverse events [ Time Frame: 12 months ]
Enrollment: 40
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with uveitis (without signs of active uveitis) related CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis, Birdshot chorioretinopathy or VKH syndrome, etc, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography and/or OCT in the studied eye
- •Total lesion area < 12 disc areas.
- •Total area of CNV within the lesion must be > 50% of total lesion.
- •Best corrected visual acuity of 20/40 to 20/320 in the study eye.
- •Willing and able to give informed consent.
排除标准
- •Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments,
- •History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
- •Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
- •Aphakia with absence of the posterior capsule in the study eye,
- •Active intraocular inflammation (grade trace or above) in the study eye,
- •Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis,
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
- •Presence of a retinal pigment epithelial tear involving the macula in the study eye,
- •Subfoveal fibrosis or atrophy in the study eye.
研究组 & 干预措施
Conbercept
The patients are followed on a monthly basis until 12 months. Three intravitreal injections of conbercept at a dosage of 0.5 mg are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months.
干预措施: Conbercept (Drug)
sham
The patients are followed on a monthly basis until 12 months. Three intravitreal sham injections are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months.
干预措施: sham (Drug)
结局指标
主要结局
Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit
时间窗: From Baseline to month 12
Compare of mean BCVA at every visit between the two groups to assess the efficacy of conbercept.
次要结局
- Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6(Baseline, month 6)
- Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 12(Baseline, month 12)
- Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12(Baseline, month 12)
- Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12(Baseline, month 3, 6 and 12)
- Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12(Baseline, month 12)
- Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 6(Baseline, month 6)
- Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit(12 months)
- Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12(Baseline, month 12)
- Number of participants with adverse events(12 months)
- Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12(Baseline, month 3, 6 and 12)
研究者
Shulin Liu
Director
Chongqing Medical University