the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Exudative Age-Related Macular Degeneration (BABAMD)

January 22, 2026 updated by: Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Ukraine
      • Odesa, Ukraine, 65061
        • The Filatov Institute of Eye Diseases and Tissue Therapy

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

Description

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.

-

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group of aflibercept
The first group (15 patients (17 eyes)) was administered intravitreal injections of 2 mg (0.05 mL) aflibercept.
Diagnostic test: laser flare photometry before intravitreal injection
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).
Active Comparator: Group of brolucizumab
The second group (15 patients (16 eyes)) received 6 mg (0.05 mL) brolucizumab.
Diagnostic test: laser flare photometry before intravitreal injection
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laser flare photometry values in the aqueous humor
Time Frame: 6-month
Detection of protein concentration in the aqueous humor using laser flare photometry
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best-corrected visual acuity
Time Frame: 6-month
the change in best-corrected visual acuity (BCVA)
6-month
central retinal thickness
Time Frame: 6-month
central retinal thickness (CRT)
6-month

Collaborators and Investigators

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

Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Investigators

  • Principal Investigator: Andrii MD Korol, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy

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)

March 25, 2021

Primary Completion (Actual)

April 15, 2023

Study Completion (Actual)

April 10, 2024

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0125U002070

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

No

Studies a U.S. FDA-regulated device product

No

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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