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NCT Number: NCT07744204

LEAP Strategy for Neovascular Age-Related Macular Degeneration

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration(nAMD) Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Laser photocoagulation

Device

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.

Anti-VEGF agents

Drug

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.

Primary outcomes

  1. Total Number of Anti-VEGF Injections Over 24 Months

    Time frame: 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.

Secondary outcomes

  1. Change in Best-Corrected Visual Acuity

    Time frame: Baseline to 24 months

    Change in BCVA from baseline to 24 months, measured using the ETDRS logarithmic visual acuity chart at 4 meters.

  2. Incidence of Subretinal or Intraretinal Fluid

    Time frame: 24 months

    Presence or absence of subretinal fluid and/or intraretinal fluid on optical coherence tomography (OCT) during follow-up.

  3. Total Number of Injections by Drug Subgroup

    Time frame: 24 months

    Comparison of the total number of anti-VEGF injections over 24 months among the four drug subgroups (conbercept, aflibercept, ranibizumab, faricimab), analyzed using a stratified Poisson regression model with interaction test between drug type and treatment regimen.

  4. Change in NEI-VFQ-25 Composite Score

    Time frame: Baseline to 24 months

    Change from baseline to 24 months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) composite score. The NEI-VFQ-25 is a 25-item questionnaire assessing vision-related quality of life. Composite scores range from 0 to 100, with higher scores indicating better vision-related functioning.

  5. Change in EQ-5D-5L Utility Index

    Time frame: Baseline to 24 months

    Change from baseline to 24 months in the EuroQol Five-Dimension Five-Level (EQ-5D-5L) utility index. The EQ-5D-5L assesses health-related quality of life across five dimensions. The utility index ranges from -0.594 to 1.000 (using the Chinese value set), with higher scores indicating better health utility. If a secondary score (EQ-VAS) is also collected, it will be reported separately.

Other outcomes

  1. Safety and Adverse Events

    Time frame: 24 months

    Incidence of adverse events, including corneal injury, ocular hypertension, lens injury, macular edema, retinal injury, and serious adverse events (endophthalmitis, retinal detachment, vitreous hemorrhage, choroidal detachment, etc.).

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Shanghai Jiao Tong University Renji Hospital Sanya Hospital
  • The 921st Hospital of the Joint Logistics Support Force of Chinese PLA

Registry information

Official study title

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

Acronym: LEAP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 4, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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