Change in Ocular Perfusion After Intravitreal Anti-VEGF in Patients with Age-related Maculopathy or Diabetic Macula Edema

Completed

• Conditions: Age Related Macular Degeneration; Diabetic Macular Edema
• Interventions: Drug: Intravitreal Aflibercept Injection; Device: Laser speckle flowgraphy

• Registration Number: NCT06878573
• Lead Sponsor: Augenabteilung Allgemeines Krankenhaus Linz

Brief Summary

This prospective study will include patients with neovascular age-related macular degeneration or diabetic macular edema, scheduled for intravitreal aflibercept. Ocular perfusion will be measured by Laser Speckle Flowgraphy (LSFG). The parameter Mean Blur Rate (MBR) reflects erythrocyte flow velocity and serves as an indirect marker of perfusion. MBR will be measured at the optic nerve head (ONH). The devices software can analyze MBR in areas of major retinal vessels (MV) and in microperfusion areas (MT) separately. Measurements will be conducted on the day of the planned intravitreal injection and one and four weeks post-injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-22
• Primary Completion: 2024-06-29
• Study Completion: 2024-07-30
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• age > 50 years,
• patients scheduled for an intravitreal injections with Aflibercept for treatment of DME or AMD.

Exclusion Criteria

• ocular surgery (including intravitreal injection) during the 3 months preceding the study
• Ametropia > 6 Dpt
• any relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. glaucoma, optic nerve head drusen, tilted disc, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age-related macular degeneration	Intravitreal Aflibercept Injection	Patients with neovascular age-related macular degeneration, requiring Anti-VEGF
Age-related macular degeneration	Laser speckle flowgraphy	Patients with neovascular age-related macular degeneration, requiring Anti-VEGF
Patients with diabetic macular edema	Intravitreal Aflibercept Injection	Patients with diabetic macular edema, requiring Anti-VEGF
Patients with diabetic macular edema	Laser speckle flowgraphy	Patients with diabetic macular edema, requiring Anti-VEGF

Primary Outcome Measures

Name	Time	Method
Mean blur rate in retinal vessels (MV)	Baseline; Week 1; Week 4;	With the onboard software, MBR can be calculated in the large vessels within the ONH (ONH-MV, "mean MBR of vascular area")

Trial Locations

Locations (1)

Department for Ophthalmology; 🇦🇹 Linz, Upper Austria, Austria