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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07375901
Acronym
BABAMD
Enrollment
30
Registered
2026-01-29
Start date
2021-03-25
Completion date
2024-04-10
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AMD

Keywords

Age-related macular degeneration,laser flare photometry, anti-VEGF, aflibercept, brolucizumab,exudative

Brief 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.

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

Interventions

DIAGNOSTIC_TESTlaser 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).

Sponsors

The Filatov Institute of Eye Diseases and Tissue Therapy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
47 Years to 88 Years
Healthy volunteers
No

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. \-

Design outcomes

Primary

MeasureTime frameDescription
laser flare photometry values in the aqueous humor6-monthDetection of protein concentration in the aqueous humor using laser flare photometry

Secondary

MeasureTime frameDescription
best-corrected visual acuity6-monththe change in best-corrected visual acuity (BCVA)
central retinal thickness6-monthcentral retinal thickness (CRT)

Countries

Ukraine

Contacts

PRINCIPAL_INVESTIGATORAndrii MD Korol, PhD

The Filatov Institute of Eye Diseases and Tissue Therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026