Age Related Macular DegenerationNCT06878573
Change in Ocular Perfusion After Intravitreal Anti-VEGF in Patients with Age-related Maculopathy or Diabetic Macula Edema
An observational study of Age Related Macular Degeneration and Diabetic Macular Edema, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- Intravitreal Aflibercept Injection and Laser speckle flowgraphy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- 22 Nov 2023to 30 Jul 2024
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian patients scheduled for intravitreal Aflibercept because of age related macular degeneration or diabetic macular edema
Who may be able to join
- age > 50 years,
- patients scheduled for an intravitreal injections with Aflibercept for treatment of DME or AMD.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Intravitreal Aflibercept Injection, Laser speckle flowgraphy
- Keywords
- ocular perfusion, laser speckle flowgraphy, anti-VEGF
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Aflibercept InjectionDrug
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.
Laser speckle flowgraphyDevice
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")
| Study group | Role | What they receive |
|---|---|---|
| Age-related macular degeneration | Patients with neovascular age-related macular degeneration, requiring Anti-VEGF Receives: Drug: Intravitreal Aflibercept Injection; Device: Laser speckle flowgraphy | |
| Patients with diabetic macular edema | Patients with diabetic macular edema, requiring Anti-VEGF Receives: Drug: Intravitreal Aflibercept Injection; Device: Laser speckle flowgraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: Baseline; Week 1; Week 4;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start22 Nov 2023
- Primary completion29 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878573
- Sponsor's protocol ID
- LSFG-aflibercept-ARMandDME
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Changes of Ocular Perfusion in Patients with Age-related Maculopathy or Diabetic Macula Edema After Intravitreal Aflibercept Injection Treatment
- ClinicalTrials.gov ID
- NCT06878573
- Acronym / sponsor ID
- LSFG-aflibercept-ARMandDME
- Keywords
- ocular perfusion, laser speckle flowgraphy, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus LinzUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age-related macular degeneration | – | Drug: Intravitreal Aflibercept Injection, Device: Laser speckle flowgraphyPatients with neovascular age-related macular degeneration, requiring Anti-VEGF |
| Patients with diabetic macular edema | – | Drug: Intravitreal Aflibercept Injection, Device: Laser speckle flowgraphyPatients with diabetic macular edema, requiring Anti-VEGF |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian patients scheduled for intravitreal Aflibercept because of age related macular degeneration or diabetic macular edema
Key inclusion criteria (2 listed)
- age > 50 years,
- patients scheduled for an intravitreal injections with Aflibercept for treatment of DME or AMD.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal Aflibercept InjectionAfter 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. | Drug | Age-related macular degeneration, Patients with diabetic macular edema |
| Laser speckle flowgraphyThe 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") | Device | Age-related macular degeneration, Patients with diabetic macular edema |
Primary outcome
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")
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Diabetic Macular Edema, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blur rate in retinal vessels (MV) (time frame: Baseline; Week 1; Week 4;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.