Focal Laser Single Intravitreal Ranibizumab Retinal Artery Macroaneurysm.

NCT05716932 | Completed DMC

• 1 other identifier: N-122-2022
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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. \[3-17\] .

Conditions

Retinal Artery Macroaneurysm

Outcome Measures

Primary Outcomes (1)

• change in best corrected visual acuity (BCVA)

  NCVA change between baseline and final follow up at 6 months

  6 months

Secondary Outcomes (2)

• change in central macular thickness (CMT)

  (Time frame: 6 months)

• incidence of complications due to laser or intravitreal injection.

  6 months

Interventions

Dual focal laser and intravitreal Ranibizumab injection PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dar El Oyoun Hospital: lead
• Cairo University: collaborator

Study Sites (1)

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Wael Ewais

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: December 22, 2022
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

EG (1)