An observational study in Retinal Arterial Macroaneurysm, sponsored by New Valley University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by New Valley University · Observational
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.
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
New Valley University is the lead sponsor of 25 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
15 patients who were diagnosed with RAM and fulfilling study certria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Time frame: 5 mnoths
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Feb 2027, 1 month later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Retinal Arterial Macroaneurysm
New Valley University