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

The Filatov Institute of Eye Diseases and Tissue Therapy

Status: Completed

Conditions: AMD

Treatments: Diagnostic Test: laser flare photometry before intravitreal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07375901

0125U002070

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 47 to 88 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group of aflibercept

Active Comparator group

Description:

The first group (15 patients (17 eyes)) was administered intravitreal injections of 2 mg (0.05 mL) aflibercept.

Treatment:

Diagnostic Test: laser flare photometry before intravitreal injection

Group of brolucizumab

Active Comparator group

Description:

The second group (15 patients (16 eyes)) received 6 mg (0.05 mL) brolucizumab.

Treatment:

Diagnostic Test: laser flare photometry before intravitreal injection