AMDBABAMDNCT07375901
the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Exudative Age-Related Macular Degeneration
A study testing laser flare photometry before intravitreal injection in people with AMD, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
Trial summary
To evaluate the status of the blood-aqueous barrier by objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP) in patients with exudative age-related macular degeneration (AMD) undergoing anti-angiogenic therapy. Read more about this study
- Who is it for?
- Ages 47 to 88 years
- Conditions the study is for
- AMD
- What is being tested?
- laser flare photometry before intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Mar 2021to 10 Apr 2024
- Phase
- Interventional
- 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 47 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: only primary, untreated patients with exudative AMD who were eligible for anti-VEGF therapy were included in the study. -
Exclusion Criteria:patients with hyperlipidemia, cardiac or renal insufficiency, ocular neoplasms, glaucoma, as well as those with corneal opacity within the optical zone or any inflammation of the studied eye that could lead to increased light-scattering intensity of protein molecules in the anterior chamber fluid, as measured by laser flare photometry, were excluded from the study.
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Trial locations and contacts
1 site in 1 country.
Ukraine1 site
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061
About this study
Official title: The State of the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Patients With Exudative Age-Related Macular Degeneration
To evaluate the status of the blood-aqueous barrier by objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP) in patients with exudative age-related macular degeneration (AMD) undergoing anti-angiogenic therapy.
Read the detailed description
All patients were assigned to two groups. The first group was administered intravitreal injections of 2 mg (0.05 mL) aflibercept, while the second group received 6 mg (0.05 mL) brolucizumab. The regimen of treatment in both groups was treat-and-extend
- Conditions
- AMD
- Being tested
- laser flare photometry before intravitreal injection
- Keywords
- Age-related macular degeneration,laser flare photometry, anti-VEGF, aflibercept, brolucizumab,exudative
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser flare photometry before intravitreal injectionDiagnostic test
The first group was administered intravitreal injections of 2 mg (0.05 mL) aflibercept The second group received 6 mg (0.05 mL) brolucizumab. Objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP).
| Study group | Role | What they receive |
|---|---|---|
| Group of aflibercept | Active comparator | The first group (15 patients (17 eyes)) was administered intravitreal injections of 2 mg (0.05 mL) aflibercept. Receives: Diagnostic Test: laser flare photometry before intravitreal injection |
| Group of brolucizumab | Active comparator | The second group (15 patients (16 eyes)) received 6 mg (0.05 mL) brolucizumab. Receives: Diagnostic Test: laser flare photometry before intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
laser flare photometry values in the aqueous humor
Detection of protein concentration in the aqueous humor using laser flare photometry
Measured: 6-month
Secondary outcomes (2)
best-corrected visual acuity
the change in best-corrected visual acuity (BCVA)
Measured: 6-month
central retinal thickness
central retinal thickness (CRT)
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start25 Mar 2021
- Primary completion15 Apr 2023
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy
- Investigators
- Andrii MD Korol, PhD, Principal investigator, The Filatov Institute of Eye Diseases and Tissue Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375901
- Sponsor's protocol ID
- 0125U002070
- Acronym
- BABAMD
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The State of the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Patients With Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07375901
- Acronym / sponsor ID
- BABAMD / 0125U002070
- Conditions
- AMD
- Keywords
- Age-related macular degeneration,laser flare photometry, anti-VEGF, aflibercept, brolucizumab,exudative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Filatov Institute of Eye Diseases and Tissue TherapyUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 29 Jan 2026 (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.
To evaluate the status of the blood-aqueous barrier by objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP) in patients with exudative age-related macular degeneration (AMD) undergoing anti-angiogenic therapy.
Detailed description
All patients were assigned to two groups. The first group was administered intravitreal injections of 2 mg (0.05 mL) aflibercept, while the second group received 6 mg (0.05 mL) brolucizumab. The regimen of treatment in both groups was treat-and-extend
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of aflibercept | Active comparator | Diagnostic Test: laser flare photometry before intravitreal injectionThe first group (15 patients (17 eyes)) was administered intravitreal injections of 2 mg (0.05 mL) aflibercept. |
| Group of brolucizumab | Active comparator | Diagnostic Test: laser flare photometry before intravitreal injectionThe second group (15 patients (16 eyes)) received 6 mg (0.05 mL) brolucizumab. |
Who may qualify
- Ages
- 47 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| laser flare photometry before intravitreal injectionThe first group was administered intravitreal injections of 2 mg (0.05 mL) aflibercept The second group received 6 mg (0.05 mL) brolucizumab. Objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP). | Diagnostic test | Group of aflibercept, Group of brolucizumab |
Primary outcome
laser flare photometry values in the aqueous humor
Time frame: 6-month
Detection of protein concentration in the aqueous humor using laser flare photometry
2 secondary outcomes
best-corrected visual acuity
Time frame: 6-month
central retinal thickness
Time frame: 6-month
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 29 Jan 2026.
- 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.
Andrii MD Korol, PhD principal investigator
The Filatov Institute of Eye Diseases and Tissue Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser flare photometry before intravitreal injection in people with AMD, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Jan 2026. 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 Ukraine. 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?
laser flare photometry values in the aqueous humor (time frame: 6-month). 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 29 Jan 2026.