Efficacy of Aflibercept With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm.
Retinal Arterial Macroaneurysm
De qué trata este estudio
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- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 15 Estimado
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Acerca de la investigación
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.
Leer la descripción completa
Retinal arterial macroaneurysm (RAM) is an acquired focal dilatation of a retinal arteriole, typically within the first three bifurcations, that may rupture or leak to cause hemorrhagic or exudative maculopathy with secondary macular edema and vision loss \[1\]. Despite its clinical significance, no standardized treatment protocol currently exists; management options range from observation to focal laser photocoagulation, anti-VEGF therapy, or a combination of both \[1,2\]. Laser photocoagulation directly targets the aneurysmal wall to induce closure and halt leakage, but carries risks of vascular occlusion, transient exudate worsening, and scotoma formation, particularly when applied to an actively leaking or edematous macula \[2\]. Anti-VEGF agents, by contrast, reduce vascular permeability and reabsorb exudation, improving visual acuity and central macular thickness, but do not reliably induce anatomical closure of the aneurysm itself \[1,2\].
High-dose intravitreal aflibercept 8 mg has recently demonstrated superior fluid resolution, durability, and extended dosing intervals compared with aflibercept 2 mg in neovascular age-related macular degeneration and diabetic macular edema in the pivotal PULSAR and PHOTON trials \[3,4\]. However, its role in RAM-associated macular edema, particularly as a pre-laser adjunct to reduce edema and inflammation before aneurysm ablation, remains unexplored.
This gap provides the rationale for the present study: to evaluate whether a loading phase of three monthly aflibercept 8 mg injections, followed by targeted laser photocoagulation of the leaking RAM site, offers a more effective, safer, and durable sequential treatment strategy for RAM-related macular edema than either modality alone
¿Quién podría participar?
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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.
Población del estudio
15 patients who were diagnosed with RAM and fulfilling study certria
Entiende la evaluación inicialTratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
evaluate the efficacy and safety of a sequential treatment protocol-comprising three consecutive monthly intravitreal injections of aflibercept 8 mg followed by focal laser photocoagulation targeted a OTHER
To assess anatomical outcomes (central macular thickness, resolution of edema, and closure of the aneurysmal leakage site) following combined pharmaco-laser therapy.
2\. To evaluate functional outcomes (best-corrected visual acuity) before and after treatment.
3\. To determine the safety profile and recurrence rate of this sequential approach over the follow-up period.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in central macular thickness (CMT), measured by spectral-domain optical coherence tomography (SD-OCT), from baseline to the final follow-up visit following sequential aflibercept 8 mg loading doses and laser photocoagulation
Plazo: 5 mnoths
Spectral-domain optical coherence tomography (SD-OCT) Heidelberg machine: central macular thickness Best-corrected visual acuity (BCVA) is measured using the ETDRS/log MAR chart.
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Abrir resultados oficiales ↗Centros de investigación (0)
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Equipo y fechas
- Patrocinador principal
- New Valley University
- Inicio del estudio
- 2027-01 Estimado
- Finalización primaria
- 2027-02 Estimado
- Finalización del estudio
- 2027-03 Estimado
- Primera publicación
- 6 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026