LEAP Strategy for Neovascular Age-Related Macular Degeneration

Starting soon · Not applicable

Conditions studied: Neovascular Age-related Macular Degeneration(nAMD), Wet Macular Degeneration

In brief

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.

Key facts

Study ID: NCT07744204
Run by: Chinese PLA General Hospital
People needed: 240
Starts: 2026-08-01
Expected to finish: 2028-07-31
Last updated by the study team: 2026-08-04

Who can join

Age: 50 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.