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

March 13, 2025 updated by: Augenabteilung Allgemeines Krankenhaus Linz

Description of the Changes of Ocular Perfusion in Patients with Age-related Maculopathy or Diabetic Macula Edema After Intravitreal Aflibercept Injection Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Department for Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Age-related macular degeneration
Patients with neovascular age-related macular degeneration, requiring Anti-VEGF
Drug: Intravitreal Aflibercept Injection
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.
Device: Laser speckle flowgraphy
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")
Patients with diabetic macular edema
Patients with diabetic macular edema, requiring Anti-VEGF
Drug: Intravitreal Aflibercept Injection
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.
Device: Laser speckle flowgraphy
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")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blur rate in retinal vessels (MV)
Time Frame: 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")
Baseline; Week 1; Week 4;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augenabteilung Allgemeines Krankenhaus Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Actual)

June 29, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSFG-aflibercept-ARMandDME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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