Efficacy and Safety of Intravitreal Conbercept With Modified Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mean change of the best-corrected visual acuity
研究概览
简要总结
This is a prospective study. Data from patients diagnosed with nAMD who have never received related treatment were collected. Treatment was an intravitreal injection of 0.5 mg conbercept using modified "T&E" treatment plans. After three months of monthly intravitreal injections, the patients were randomly divided into two groups, and the degree of adjustment of the injection interval was divided into two weeks and four weeks. Unlike the ALTAIR study, we cancel the maintenance criteria of classical T&E regimens. The best-corrected visual acuity (BCVA), central retinal thickness (CRT), last injection interval, and the number of injections were recorded at 3, 6, 12, and 24 months to evaluate treatment efficacy.
详细描述
This is a prospective study. Data from patients diagnosed with nAMD who have never received related treatment were collected. Treatment was an intravitreal injection of 0.5 mg conbercept using modified "T&E" treatment plans. After three months of monthly intravitreal injections, the patients were randomly divided into two groups, and the degree of adjustment of the injection interval was divided into two weeks and four weeks. Unlike the ALTAIR study, we cancel the maintenance criteria of classical T&E regimens. The best-corrected visual acuity (BCVA), central retinal thickness (CRT), last injection interval, and the number of injections were recorded at 3, 6, 12, and 24 months to evaluate treatment efficacy.
Randomization and Interventions Conbercept (0.5 mg) was injected intravitreally once a month for 3 months, and then the patients were randomly divided into a 2-week group and a 4-week group. 2-week group: The injection interval was adjusted to 2 weeks. 4-week group: The injection interval was adjusted to 4 weeks. In the 2-week group, if the visual acuity decreased by less than 5 letters and the lesions showed no signs of exudative activity, such as rebleeding and increased oedema, the patients were followed up 6 weeks after the third injection and injected intravitreally once. If the condition remained stable, the follow-up was extended to 8 weeks , vitreous infusion was performed, and then the vitreous injection interval was gradually extended. If visual acuity decreased by more than 5 letters or the lesions showed rebleeding, increased oedema and other anatomical indicators worsened, a 4-week injection interval was maintained or reduced to 2 weeks based on the extended injection interval. In the 4-week group, the patients were followed up 8 weeks after the third injection and injected intravitreally once. If the condition remained stable, the follow-up was extended to 12 weeks, and vitreous injection was performed. Then, the vitreous injection interval was gradually extended.
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)
盲法说明
Peng Hui, chief physician of Ophthalmology Department of the First Affiliated Hospital of Chongqing Medical University, randomly divided the enrolled patients into two groups when they only knew the patient number and did not know the specific situation of the patient.
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥50 years and meeting the diagnostic criteria for exudative AMD
- •OCTA suggesting the presence of subretinal neovascularization
- •no prior treatment (anti-VEGF, PDT, etc.)
- •best-corrected visual acuity (BCVA) between 5-75 letters in the study eye.
排除标准
- •allergy to drugs needed in the diagnosis and treatment
- •a history of internal eye surgery (except surgery about cataract), trauma, or fundus laser photocoagulation
- •other ophthalmologic diseases besides nAMD or cataracts
- •renal insufficiency and severe cardiovascular and cerebrovascular diseases
- •surgery required due to vitreous hemorrhage during follow-up treatment
- •recent preparation for childbirth, pregnancy or lactation
- •poor compliance with diagnosis and treatment or difficulty conducting a regular outpatient review and cooperating with treatment.
研究组 & 干预措施
2 week group
Drug injection adjustment interval is 2 weeks
干预措施: different degrees of adjustment of the injection interval (Drug)
4 week group
Drug injection adjustment interval is 4 weeks
干预措施: different degrees of adjustment of the injection interval (Drug)
结局指标
主要结局
mean change of the best-corrected visual acuity
时间窗: baseline, every time before pre-intervention
change of the best-corrected visual acuity
次要结局
- mean number of injections(up to 2 years)
- mean change of central retinal thickness(baseline, every time before pre-intervention)
- mean time of last injection interval(up to 2 years)
- the rate of complications or adverse reactions(up to 2 years)
研究者
Hui Peng
Chief Physician
First Affiliated Hospital of Chongqing Medical University