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

NCT06878573 | Completed DMC FDA Drug FDA Device

• 1 other identifier: LSFG-aflibercept-ARMandDME
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration; Diabetic Macular Edema

Keywords

ocular perfusion; laser speckle flowgraphy; anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Mean blur rate in retinal vessels (MV)

  With the onboard software, MBR can be calculated in the large vessels within the ONH (ONH-MV, "mean MBR of vascular area")

  Baseline; Week 1; Week 4;

Study Arms (2)

Age-related macular degeneration

Patients with neovascular age-related macular degeneration, requiring Anti-VEGF

Drug: Intravitreal Aflibercept Injection; Device: Laser speckle flowgraphy

Patients with diabetic macular edema

Patients with diabetic macular edema, requiring Anti-VEGF

Drug: Intravitreal Aflibercept Injection; Device: Laser speckle flowgraphy

Interventions

Intravitreal Aflibercept Injection DRUG

After instillation of topical anesthesia (0.4% oxybuprocaine hydrochloride and lidocain; own production), sterilization of the eyelid (Betaisodona solution 11% povidone-iodine, Mundipharma, Limburg, Germany), and instillation of 1.25% povidone-iodine drops, 2.0 mg/0.05 mL of aflibercept (Eylea) will be injected into the vitreous cavity through a standard pars plana approach (3.5 mm posterior to the limbus) under sterile conditions.

Age-related macular degeneration; Patients with diabetic macular edema

Laser speckle flowgraphy DEVICE

The RetFlow consists of a fundus camera equipped with a diode laser at a wavelength of 830 nm and a digital charge-coupled device camera (750 x 360 pixels). A total of 118 images are acquired at a rate of 30 frames per second over a 4-second measurement period. The main output parameter of LSFG, mean blur rate (MBR), is calculated from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. MBR was calculated for the total ONH area, defined by a ellipsoid region of interest (ROI). By using the on-board software, the MBR will be calculated in the large vessels within the ONH (ONH-MV, "mean MBR of vascular area") and the tissue area containing the microvasculature (ONH-MT, "mean MBR of tissue area")

Age-related macular degeneration; Patients with diabetic macular edema

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian patients scheduled for intravitreal Aflibercept because of age related macular degeneration or diabetic macular edema

You may qualify if:

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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Augenabteilung Allgemeines Krankenhaus Linz: lead

Study Sites (1)

Department for Ophthalmology

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 17, 2025
• Study Start: November 22, 2023
• Primary Completion: June 29, 2024
• Study Completion: July 30, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)