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NCT Number: NCT07375901

the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in 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.

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Key information

Conditions

AMD Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

47 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

laser flare photometry before intravitreal injection

Diagnostic 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).

Primary outcomes

  1. laser flare photometry values in the aqueous humor

    Time frame: 6-month

    Detection of protein concentration in the aqueous humor using laser flare photometry

Secondary outcomes

  1. best-corrected visual acuity

    Time frame: 6-month

    the change in best-corrected visual acuity (BCVA)

  2. central retinal thickness

    Time frame: 6-month

    central retinal thickness (CRT)

Sponsors and collaborators

Lead sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Other

Registry information

Official study title

The State of the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Patients With Exudative Age-Related Macular Degeneration

Acronym: BABAMD

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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