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CompletedNCT05716932RAMUpdated Feb 8, 2023

Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.

An observational study in Retinal Artery Macroaneurysm, sponsored by Dar El Oyoun Hospital. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Dar El Oyoun Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
14
Sex
All
01

Study summary

Treatment options for Retinal artery Macroaneurysm (RAM) include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]

However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]

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Read the detailed description

Retinal arterial macroaneurysm (RAM) is an acquired localized arterial dilatation, which often occurs at second or third branches of the central retinal artery. Mostly, elderly hypertensive females above 60 years are affected. One in 4500 people over the age of 40 years is liable to develop a RAM. It may be associated with retinal vein occlusion. [1]

The natural history of a RAM can be divided into a growing phase, followed by gradual fibrosis and/ or thrombosis (closure), and then involution. A growing macroaneurysm may leak, resulting in intraretinal exudation and macular edema. It may rupture producing subretinal, intraretinal, preretinal, and / or vitreous hemorrhage. Approximately 8%-25% of RAMs undergo spontaneous involution without treatment. However, treatment is required for leaking macroaneurysms to prevent macular structural damage. [2,3]

Treatment options for RAM include focal laser photocoagulation, intravitreal anti-Vascular Endothelial Growth Factor (anti-VEGF) injection, combined anti VEGF - laser therapy, YAG hyaloidotomy and pars plana vitrectomy. Focal laser photocoagulation is applied directly to the macroaneurysm (direct lesional), its surrounding area (indirect perilesional) or a combination of both. [3-5] Anti-VEGF agents including bevacizumab and ranibizumab reduce leakage from the macroaneurysm. [3-15] YAG hyaloidotomy is used for fresh premacular hemorrhage. [16] Pars plana vitrectomy is reserved for RAM complicated by vitreous and/or premacular hemorrhage. [17]

However, there is no consensus about laser and anti VEGF treatments. Some authors use perilesional laser, while others use direct laser only. There is also no clear protocol for anti VEGF injections. Some authors report using focal laser only if multiple anti VEGF injections do not result in marked improvement. [3-17]

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Conditions studied

  • Retinal Artery Macroaneurysm
03

In context

Lead sponsor

Dar El Oyoun Hospital is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Retrospective review of records of eyes with RAM; treated between February 2012 and November 2020; will be done, to collect and analyze the following data: Treatment details, features of RAM, associated retinal disease, best-corrected visual acuity (BCVA), central macular thickness (CMT), signs of RAM involution, and possible complications

Inclusion criteria

  • We will enroll cases of RAM that had been treated by Direct and perilesional focal laser, followed by a single intravitreal ranibizumab injection a few days later, and had been followed up for at least 6 months

Exclusion criteria

Exclusion Criteria:

    • RAM treated by a single approach (laser or intravitreal injections),

      • RAM treated by other anti-VEGF injections (not ranibizumab),
      • RAM with a shorter than 6 months of follow-up after combined laser and ranibizumab
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • ProcedureDual focal laser and intravitreal Ranibizumab injection

    Direct and perilesional focal laser followed by a single intravitreal 0.5 mg ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA, USA) injection

    Also known as: DFL and IVR

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What researchers measure

Primary outcomes

  1. change in best corrected visual acuity (BCVA)

    NCVA change between baseline and final follow up at 6 months

    Time frame: 6 months

Secondary outcomes

  1. change in central macular thickness (CMT)

    between baseline and final follow up at 6 months

    Time frame: (Time frame: 6 months)

  2. incidence of complications due to laser or intravitreal injection.

    presence or absence of complications

    Time frame: 6 months

07

Study locations

1 site
  • Kasr alainy faculty of medicine
    Cairo, 12311, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05716932
Lead sponsor
Dar El Oyoun Hospital
Collaborators
Cairo University
Responsible party
Wael Ahmed Ewais (Dr Wael Ewais, Dar El Oyoun Hospital) — Principal investigator
First posted
Feb 8, 2023
Start date
Dec 22, 2022
Primary completion
Jan 21, 2023
Completion
Jan 21, 2023
Last update
Feb 8, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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