NCT07744204Not yet recruiting
LEAP Strategy for Neovascular Age-Related Macular Degeneration
Laser-Enhanced Anti-VEGF Precise Penetration (LEAP) Strategy for Neovascular Age-Related Macular Degeneration: A Multicentre, Prospective, Stratified Block-Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Macular degeneration
- NCT number
- NCT07744204
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 1 Aug 2026 to the primary completion date, 31 Jul 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in other clinical trials
Other illness
- 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
- 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
- Transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiovascular event requiring hospitalization within the past 4 months
Lab values
- Poorly controlled blood glucose in diabetic patients
Other
- Active MNV entirely located within 300 μm of the foveal centre
Who the study is looking for
- 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
Age in the registry: 50 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.