Retinal Arterial MacroaneurysmNCT07922824
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
An observational study of Retinal Arterial Macroaneurysm, run by New Valley University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Arterial Macroaneurysm
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Mar 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 patients who were diagnosed with RAM and fulfilling study certria
Who may be able to join
None listed.
Who cannot join
- RAM leakage site inaccessible to laser photocoagulation (e.g., juxtafoveal or subfoveal location precluding safe laser application).
- Significant vitreous hemorrhage precluding adequate fundus visualization or laser delivery.
- Known hypersensitivity to aflibercept or any component of its formulation. 4. Pregnancy or breastfeeding.
- 5-Systemic conditions precluding safe intravitreal injection (e.g., recent stroke or myocardial infarction within 3 months, uncontrolled thromboembolic disease).
- 6-Media opacity precluding adequate OCT/FFA imaging or laser treatment (e.g., dense cataract, corneal opacity).
About this study
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.
Read more
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.
Read the detailed description
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
- Conditions
- Retinal Arterial Macroaneurysm
- Being tested
- 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
- Medical subject headings
- Retinal Arterial Macroaneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 aOther
To assess anatomical outcomes (central macular thickness, resolution of edema, and closure of the aneurysmal leakage site) following combined pharmaco-laser therapy.
- To evaluate functional outcomes (best-corrected visual acuity) before and after treatment.
- To determine the safety profile and recurrence rate of this sequential approach over the follow-up period.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 mnoths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Arterial MacroaneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Asmaa Kamel Ahmed Hassan, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922824
- Sponsor's protocol ID
- EASLPMESRAM
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
- ClinicalTrials.gov ID
- NCT07922824
- Acronym / sponsor ID
- EASLPMESRAM
- Conditions
- Retinal Arterial Macroaneurysm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 patients who were diagnosed with RAM and fulfilling study certria
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- RAM leakage site inaccessible to laser photocoagulation (e.g., juxtafoveal or subfoveal location precluding safe laser application).
- Significant vitreous hemorrhage precluding adequate fundus visualization or laser delivery.
- Known hypersensitivity to aflibercept or any component of its formulation. 4. Pregnancy or breastfeeding.
- 5-Systemic conditions precluding safe intravitreal injection (e.g., recent stroke or myocardial infarction within 3 months, uncontrolled thromboembolic disease).
- 6-Media opacity precluding adequate OCT/FFA imaging or laser treatment (e.g., dense cataract, corneal opacity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 aTo 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. | Other | – |
Primary outcome
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Arterial Macroaneurysm, run by New Valley University.
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 0 inclusion and 5 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 6 Nov 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?
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 (time frame: 5 mnoths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.