Efficacy of Aflibercept With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm.

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

15 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Retinal arterial macroaneurysm (RAM) is an acquired dilatation of a retinal arteriole that can rupture or leak, causing hemorrhage, exudation, macular edema, and vision loss. No standardized treatment exists, and options range from observation to laser photocoagulation, anti-VEGF therapy, or both.

Laser photocoagulation closes the aneurysm directly and stops leakage. It risks vascular occlusion, temporary worsening of exudate, and scotomas, especially in an actively leaking or edematous macula.

Anti-VEGF therapy reduces vascular permeability and exudation, improving visual acuity and central macular thickness. It does not reliably close the aneurysm itself.

High-dose aflibercept 8 mg has outperformed aflibercept 2 mg in fluid resolution, durability, and dosing interval length in neovascular AMD and diabetic macular edema (PULSAR and PHOTON trials). Its role in RAM-related macular edema, particularly as a pre-laser step to reduce edema and inflammation, has not been studied.

Study rationale: The study will test whether three monthly aflibercept 8 mg loading injections followed by targeted laser to the leaking RAM is a more effective, safer, and more durable sequential strategy than either treatment alone.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion criteria;

1. Age ≥ 18 years, of either sex.
2. Clinical and imaging-confirmed diagnosis of retinal arterial macroaneurysm
3. Presence of macular edema secondary to RAM.
4. Treatment-naïve eyes.
5. Signed informed consent

Exclusion criteria:

1. RAM leakage site inaccessible to laser photocoagulation.
2. Significant vitreous hemorrhage.
3. Known hypersensitivity to aflibercept.
4. Pregnancy or breastfeeding.
5. Systemic conditions precluding safe intravitreal injection.
6. Media opacity precluding adequate visualization.

Study population

15 patients who were diagnosed with RAM and fulfilling study certria

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor

New Valley University

Study start

2027-01 Estimated

Primary completion

2027-02 Estimated

Study completion

2027-03 Estimated

First posted

Nov 6, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.