Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-04-01
2022-04-01
Brief Summary
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Detailed Description
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This study is planned as a randomized, multicenter, open-label, comperative, interventional. Patients with myopia included in it will receive brolucizumab or aflibercept.
The treatment proposed in this study is based on the world experience and scientific developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine". Therefore, it is expected that the benefit/risk ratio in relation to the participation in this study should not be different from that described in the scientific literature and the benefits outweigh the risk. It is known that the absence of treatment in these diseases leads to an irreparable loss of central vision.
Patients with a pathologic myopia with CNV (native) will be treated with antiangiogenic drugs according to the regimen pro re nata.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brolucizumab
Arm B
Intravitreal injection
Intravitreal injection to the regimen pro re nata
Aflibercept
Arm A
Intravitreal injection
Intravitreal injection to the regimen pro re nata
Interventions
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Intravitreal injection
Intravitreal injection to the regimen pro re nata
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* Any prior treatment with photodynamic therapy in the study eye.
* Cataract surgery within 3 months prior to Day 1 in the study eye.
* Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye.
* Any other intraocular surgery within 3 months prior to Day 1 in the study eye.
* History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.
* Any prior treatment with anti-VEGF agents
* Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1
* Previous assignment to treatment during this study
* Uncontrolled hypertension
* History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications
* Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study.
* Renal failure requiring dialysis or renal transplant
* Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device
* Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin
* Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality
18 Years
80 Years
ALL
No
Sponsors
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Odessa National Medical University
OTHER
Mykolaiv Region Ophthalmogical Hospital
OTHER
Central Polyclinic of Internal Affairs of Ukraine
OTHER_GOV
Lesya Ukrainka Volyn National University
OTHER
The Filatov Institute of Eye Diseases and Tissue Therapy
OTHER
Responsible Party
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Andrii Korol, MD, PhD
Head of Laser Department
Principal Investigators
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Andrii MD Korol, PhD
Role: PRINCIPAL_INVESTIGATOR
The Filatov Institute of Eye Diseases and Tissue Therapy
Locations
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Lesya Ukrainka Volyn National University
Lutsk, , Ukraine
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, , Ukraine
Odessa National Medical University
Odesa, , Ukraine
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Nadiia MD Ulianova, PhD
Role: primary
Krasymira MD Rylkovа, PhD
Role: primary
Nadiia MD Ulianova, PhD
Role: primary
References
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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.
Other Identifiers
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0118U001612m
Identifier Type: -
Identifier Source: org_study_id
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