Laser-Enhanced Anti-VEGF Precise Penetration (LEAP) Strategy for Neovascular Age-Related Macular Degeneration: A Multicentre, Prospective, Stratified Block-Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Total Number of Anti-VEGF Injections Over 24 Months
研究概览
简要总结
Background: Age-related macular degeneration (AMD) is a common eye disease that can cause blindness in older adults. The "wet" form of AMD, called neovascular AMD, happens when abnormal blood vessels grow under the retina and leak fluid. The current standard treatment requires repeated eye injections of anti-VEGF drugs, often every month or every few months. This frequent injection schedule is a heavy burden for patients and many cannot keep up with the treatment plan.
Purpose: This study tests whether a single session of low-intensity laser applied to the diseased area, given just before the anti-VEGF injection, can help the drug reach the target more effectively. If this works, patients may need far fewer injections over time.
Intervention: Participants will be randomly assigned to one of two groups. The experimental group will receive the laser treatment followed by an anti-VEGF injection within 6 hours. The control group will receive the anti-VEGF injection alone, according to the current standard regimen. Four different anti-VEGF drugs are allowed in this study: conbercept, aflibercept, ranibizumab, and faricimab.
Participants: The study plans to enroll at least 240 patients with active neovascular AMD across five hospitals in China. All participants must be at least 50 years old and meet specific eligibility criteria.
Follow-up: All participants will be followed for 24 months with monthly clinic visits. The study will record the total number of injections received, changes in vision, fluid status on eye scans, and any side effects.
Primary Outcome: The main measure is the total number of anti-VEGF injections each participant needs over the 24-month period. The study will compare the experimental group and the control group to see whether the laser-enhanced approach reduces the injection frequency.
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
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years, male or female
- •Diagnosed with neovascular age-related macular degeneration (nAMD) based on multimodal imaging (fundus photography, OCT, FFA, ICGA), including type 1, type 2, or type 3 MNV, or PCV
- •Clear ocular media and adequate pupillary dilation to permit OCT, fundus photography, angiography, and laser photocoagulation
- •Active MNV in the study eye at least partially located ≥ 300 μm from the foveal centre
- •Willing and able to provide written informed consent
- •Only one eye per subject enrolled; if both eyes eligible, the study eye is selected by the investigator
排除标准
- •Active MNV entirely located within 300 μm of the foveal centre
- •Significant hemorrhage obscuring the active MNV lesion on FFA/ICGA Unwilling or unable to provide informed consent, refusal of randomization, or inability to complete scheduled follow-up visits
- •Concurrent participation in other clinical trials
- •Contraindication or allergy to FFA/ICGA
- •Coexisting ocular conditions that may affect visual acuity during follow-up (e.g., cataract, diabetic retinopathy, retinal vascular occlusion, uveitis, neovascular glaucoma)
- •Severe ocular surface infection (e.g., conjunctivitis, severe blepharitis)
- •Uncontrolled hypertension (blood pressure > 180/110 mmHg) despite antihypertensive therapy
- •Any condition in the study eye or systemically that, in the investigator's opinion, would pose significant risk to the participant
- •Poorly controlled blood glucose in diabetic patients
- •Transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiovascular event requiring hospitalization within the past 4 months
研究组 & 干预措施
LEAP (Laser-Enhanced Anti-VEGF Precise Penetration)
Participants in this arm receive a single session of 577-nm laser photocoagulation applied to the active macular neovascularization lesion (located ≥ 300 μm from the foveal centre), followed by an intravitreal injection of anti-VEGF agent (conbercept, aflibercept, ranibizumab, or faricimab) within 6 hours after laser. Retreatment during the 24-month follow-up is repeated when signs of active disease recur, using the same combination therapy.
干预措施: Laser photocoagulation (Device)
LEAP (Laser-Enhanced Anti-VEGF Precise Penetration)
Participants in this arm receive a single session of 577-nm laser photocoagulation applied to the active macular neovascularization lesion (located ≥ 300 μm from the foveal centre), followed by an intravitreal injection of anti-VEGF agent (conbercept, aflibercept, ranibizumab, or faricimab) within 6 hours after laser. Retreatment during the 24-month follow-up is repeated when signs of active disease recur, using the same combination therapy.
干预措施: Anti-VEGF agents (Drug)
Conventional Treatment Group
Participants in this arm receive intravitreal injection of anti-VEGF agent (conbercept, aflibercept, ranibizumab, or faricimab) alone according to the standard 3+PRN (pro re nata) regimen. Retreatment during the 24-month follow-up is given when signs of active disease recur, using anti-VEGF injection alone.
干预措施: Anti-VEGF agents (Drug)
结局指标
主要结局
Total Number of Anti-VEGF Injections Over 24 Months
时间窗: 24 months
The total number of intravitreal anti-VEGF injections administered to each participant during the 24-month follow-up period, compared between the LEAP group and the conventional treatment group.
次要结局
- Change in Best-Corrected Visual Acuity(Baseline to 24 months)
- Incidence of Subretinal or Intraretinal Fluid(24 months)
- Total Number of Injections by Drug Subgroup(24 months)
- Change in NEI-VFQ-25 Composite Score(Baseline to 24 months)
- Change in EQ-5D-5L Utility Index(Baseline to 24 months)
研究者
Houbin Huang
Director, Senior Department of Ophthalmology, PLA General Hospital
Chinese PLA General Hospital