NCT07375901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

AMD

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • laser flare photometry values in the aqueous humor

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

    6-month

Secondary Outcomes (2)

  • best-corrected visual acuity

    6-month

  • central retinal thickness

    6-month

Study Arms (2)

Group of aflibercept

ACTIVE COMPARATOR

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

Group of brolucizumab

ACTIVE COMPARATOR

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

Diagnostic Test: laser flare photometry before intravitreal injection

Interventions

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).

Group of afliberceptGroup of brolucizumab

Eligibility Criteria

Age47 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Andrii MD Korol, PhD

    The Filatov Institute of Eye Diseases and Tissue Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Official Title: MD, PhD, DMedSc,Prof

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

March 25, 2021

Primary Completion

April 15, 2023

Study Completion

April 10, 2024

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)