Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.

Retinal Artery Macroaneurysm Clinical Trial

— RAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716932
• Other study ID #: N-122-2022
• Status: Completed
• Start date: December 22, 2022
• Est. completion date: January 21, 2023

Study information

• Verified date: January 2023
• Source: Dar El Oyoun Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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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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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 21, 2023
• Est. primary completion date: January 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Artery Macroaneurysm

Intervention

Procedure:
• Dual 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

Locations

Country	Name	City	State
Egypt	Kasr alainy faculty of medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Dar El Oyoun Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in best corrected visual acuity (BCVA)	NCVA change between baseline and final follow up at 6 months	6 months
Secondary	change in central macular thickness (CMT)	between baseline and final follow up at 6 months	(Time frame: 6 months)
Secondary	incidence of complications due to laser or intravitreal injection.	presence or absence of complications	6 months