Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.

Completed

• Conditions: Retinal Artery Macroaneurysm

• Registration Number: NCT05716932
• Lead Sponsor: Dar El Oyoun Hospital

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. \[3-17\]

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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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Study Timeline

• Study Start: 2022-12-22
• Status Verified: 2023-01
• Primary Completion: 2023-01-21
• Study Completion: 2023-01-21
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in best corrected visual acuity (BCVA)	6 months	NCVA change between baseline and final follow up at 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kasr alainy faculty of medicine; 🇪🇬 Cairo, Egypt