Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT05716932
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.
Sponsor:
Dar El Oyoun Hospital
Organization:
Study Overview
Official Title:
Validity of Focal Laser Photocoagulation Followed by a Single Intravitreal Ranibizumab Injection for Retinal Artery Macroaneurysm.
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAM
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. \[3-17\]
.
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. \[3-17\]
.
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. \[3-17\]
.
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. \[3-17\]
.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: