LEAP Strategy for Neovascular Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Laser photocoagulation
Device577-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
DrugIntravitreal 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: LEAP (Laser-Enhanced Anti-VEGF Precise Penetration)Experimental treatment 2 interventions
Group B: Conventional Treatment GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Number of Anti-VEGF Injections Over 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.
Time frame
24 monthsSecondary outcomes
1
Change in Best-Corrected Visual Acuity
Change in BCVA from baseline to 24 months, measured using the ETDRS logarithmic visual acuity chart at 4 meters.
Time frame
Baseline to 24 months2
Incidence of Subretinal or Intraretinal Fluid
Presence or absence of subretinal fluid and/or intraretinal fluid on optical coherence tomography (OCT) during follow-up.
Time frame
24 months3
Total Number of Injections by Drug Subgroup
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.
Time frame
24 months4
Change in NEI-VFQ-25 Composite Score
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.
Time frame
Baseline to 24 monthsOther outcomes
1
Safety and Adverse Events
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.).
Time frame
24 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
The 921st Hospital of the Joint Logistics Support Force of Chinese PLA
Collaborator
Shanghai Jiao Tong University Renji Hospital Sanya Hospital
Collaborator
Source ClinicalTrials.gov
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