LEAP Strategy for Neovascular Age-Related Macular Degeneration

Официальное название

Laser-Enhanced Anti-VEGF Precise Penetration (LEAP) Strategy for Neovascular Age-Related Macular Degeneration: A Multicentre, Prospective, Stratified Block-Randomised Controlled Trial

Обзор

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.

Вмешательства

• Устройство Laser photocoagulation
  577-nm yellow laser photocoagulation with a spot size of 200 μm, exposure time of 0.1-0.2 seconds, applied to the active macular neovascularization lesion located ≥ 300 μm from the foveal centre, with laser power adjusted to produce grade II to mild III burns. Laser is performed within one week after randomization and repeated when signs of active disease recur during follow-up.
• Препарат Anti-VEGF agents
  Intravitreal injection of anti-VEGF agents, including conbercept, aflibercept, ranibizumab, or faricimab. The specific drug is selected based on stratification and clinical indication. Injection is administered under sterile conditions using standard aseptic technique, with needle insertion 3.5-4 mm posterior to the limbus.

Первичные конечные точки

• Total Number of Anti-VEGF Injections Over 24 Months [Срок оценки: 24 months]

Вторичные конечные точки (5)

• Change in Best-Corrected Visual Acuity [Срок оценки: Baseline to 24 months]
• Incidence of Subretinal or Intraretinal Fluid [Срок оценки: 24 months]
• Total Number of Injections by Drug Subgroup [Срок оценки: 24 months]
• Change in NEI-VFQ-25 Composite Score [Срок оценки: Baseline to 24 months]
• Change in EQ-5D-5L Utility Index [Срок оценки: Baseline to 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07744204 · KY2025-045 · 23BJZ37, 19BJZ39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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