RAM: Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.

Sponsor

Dar El Oyoun Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05716932

Collaborator

Cairo University (Other)

Enrollment

Location

Actual Duration (Days)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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]

Condition or Disease	Intervention/Treatment	Phase
Retinal Artery Macroaneurysm	Procedure: Dual focal laser and intravitreal Ranibizumab injection

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]

Study Design

Study Type:

Observational

Actual Enrollment :

14 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.

Actual Study Start Date :

Dec 22, 2022

Actual Primary Completion Date :

Jan 21, 2023

Actual Study Completion Date :

Jan 21, 2023

Outcome Measures

Primary Outcome Measures

change in best corrected visual acuity (BCVA) [6 months]
NCVA change between baseline and final follow up at 6 months

Secondary Outcome Measures

change in central macular thickness (CMT) [(Time frame: 6 months)]
between baseline and final follow up at 6 months
incidence of complications due to laser or intravitreal injection. [6 months]
presence or absence of complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy faculty of medicine	Cairo		Egypt	12311

Sponsors and Collaborators

Dar El Oyoun Hospital
Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wael Ahmed Ewais, Dr Wael Ewais, Dar El Oyoun Hospital

ClinicalTrials.gov Identifier:

NCT05716932

Other Study ID Numbers:

N-122-2022

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ranibizumab

Study Results

No Results Posted as of Feb 8, 2023