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LEAP Strategy for Neovascular Age-Related Macular Degeneration

NCT07744204 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-08-04

No results posted yet for this study

Summary

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.

Conditions

  • Neovascular Age-related Macular Degeneration(nAMD)
  • Wet Macular Degeneration

Interventions

DEVICE

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.

DRUG

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.

Sponsors & Collaborators

  • The 921st Hospital of the Joint Logistics Support Force of Chinese PLA

    collaborator UNKNOWN

  • Shanghai Jiao Tong University Renji Hospital Sanya Hospital

    collaborator UNKNOWN

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-07-31
Completion
2028-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744204 on ClinicalTrials.gov