Brolucizumab for CNV Associated With Pathologic Myopia
COASTUAbaCNV
Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Pathologic Myopia
1 other identifier
interventional
50
1 country
4
Brief Summary
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
4 active sites
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
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMarch 24, 2022
March 1, 2022
1 year
July 19, 2021
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.
Baseline-Month 12
Secondary Outcomes (3)
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT)
Baseline-Month 12
Average Number of Intravitreal Injections
Baseline-Month 12
Number of Inflamations after Intravitreal Injections
Baseline-Month 12
Study Arms (2)
Brolucizumab
ACTIVE COMPARATORArm B
Aflibercept
ACTIVE COMPARATORArm A
Interventions
Intravitreal injection to the regimen pro re nata
Eligibility Criteria
You may qualify if:
- Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form.
- Signed informed consent form.
- Men and women ≥ 18 years of age.
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
- Myopia of greater than or equal to -6 D OR axial length of greater than (if the spherical myopic equivalent is \<6.0 diopters, then the patient should have myopic changes in the macula: lacquer cracks, focal chorioretinal atrophy, posterior staphyloma) or equal to 26.5 mm.
- Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to pathologic myopia as defined by leakage on FA.
- Transparent optical media and possibility to mydriasis.
- Best corrected visual acuity at least 20/200 Equivalent of Snellen (ETDRS).
You may not qualify if:
- Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
- Recurrent mCNV in the study eye
- History or presence of CNV with an origin other than pathologic myopia in the study eye
- Ocular inflammation or external ocular inflammation in the study eye
- Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period
- Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results
- Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye
- Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
- Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye
- Any iris neovascularization and/or vitreous hemorrhage in either eye
- Uncontrolled glaucoma, or previous filtration surgery in either eye
- Prior and concomitant treatments
- Any prior or concomitant treatment with another investigational agent for mCNV in the study eye.
- Any previous panretinal photocoagulation or subfoveal thermal laser therapy in the study eye.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lesya Ukrainka Volyn National University
Lutsk, 43025, Ukraine
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, 54000, Ukraine
Odessa National Medical University
Odesa, 65028, Ukraine
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061, Ukraine
Related Publications (1)
Korol AR, Zadorozhnyy OS, Naumenko VO, Kustryn TB, Pasyechnikova NV. Intravitreal aflibercept for the treatment of choroidal neovascularization associated with pathologic myopia: a pilot study. Clin Ophthalmol. 2016 Nov 4;10:2223-2229. doi: 10.2147/OPTH.S117791. eCollection 2016.
PMID: 27853350BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrii MD Korol, PhD
The Filatov Institute of Eye Diseases and Tissue Therapy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Laser Department
Study Record Dates
First Submitted
July 19, 2021
First Posted
July 26, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
March 24, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share