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Neovascular Age-related Macular Degeneration(nAMD)LEAPNCT07744204

LEAP Strategy for Neovascular Age-Related Macular Degeneration

A study testing Laser photocoagulation and Anti-VEGF agents in people with Neovascular Age-related Macular Degeneration(nAMD) and Wet Macular Degeneration, run by Chinese PLA General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
Laser photocoagulation and Anti-VEGF agents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 31 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

About this study

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

Read more

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.

Being tested
Laser photocoagulation, Anti-VEGF agents
Medical subject headings
Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser photocoagulationDevice

    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 agentsDrug

    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.

Study groups in NCT07744204
Study groupRoleWhat they receive
LEAP (Laser-Enhanced Anti-VEGF Precise Penetration)ExperimentalParticipants in this arm receive a single session of 577-nm laser photocoagulation applied to the active macular neovascularization lesion (located ≥ 300 μm from the foveal centre), followed by an intravitreal injection of anti-VEGF agent (conbercept, aflibercept, ranibizumab, or faricimab) within 6 hours after laser. Retreatment during the 24-month follow-up is repeated when signs of active disease recur, using the same combination therapy.
Receives: Device: Laser photocoagulation; Drug: Anti-VEGF agents
Conventional Treatment GroupActive comparatorParticipants in this arm receive intravitreal injection of anti-VEGF agent (conbercept, aflibercept, ranibizumab, or faricimab) alone according to the standard 3+PRN (pro re nata) regimen. Retreatment during the 24-month follow-up is given when signs of active disease recur, using anti-VEGF injection alone.
Receives: Drug: Anti-VEGF agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (5)

  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.

    Measured: Baseline to 24 months

  2. Incidence of Subretinal or Intraretinal Fluid

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

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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.

    Measured: Baseline to 24 months

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

    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.

    Measured: Baseline to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07744204
Sponsor's protocol ID
KY2025-045
Other IDs
23BJZ37, 19BJZ39
Acronym
LEAP
Status last verified
Aug 2026
First submitted
22 Jul 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Laser photocoagulation and Anti-VEGF agents in people with Neovascular Age-related Macular Degeneration(nAMD) and Wet Macular Degeneration, run by Chinese PLA General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Anti-VEGF Injections Over 24 Months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07744204.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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