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NCT07922824
Efficacy of Aflibercept With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm.
Conditions: Retinal Arterial Macroaneurysm
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 15
Sponsor: New Valley University
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07922824). StuddyBuddy aggregates publicly available trial information.