Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.

Detailed Description
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The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia. This study is planned as a follow-up. Patients with myopia included in it will receive antiangiogenic therapy in accordance with the approved indications for use indicated in the instructions for the use of drugs in Ukraine. 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.

Official Title
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Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia

Conditions
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Pathologic Myopia

Intervention / Treatment
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* Procedure: Intravitreal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). - Exclusion Criteria: 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 Any prior treatment with photodynamic therapy in the study eye. 17. Cataract surgery within 3 months prior to Day 1 in the study eye. 18. Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye. 19. Any other intraocular surgery within 3 months prior to Day 1 in the study eye. 20. History of vitreoretinal surgery and/or scleral buckle surgery in the study eye. 21. Any prior treatment with anti-VEGF agents 22. Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1 23. Previous assignment to treatment during this study 24. Uncontrolled hypertension 25. History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1 26. 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 27. 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. 28. Renal failure requiring dialysis or renal transplant 29. 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 30. Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin 31. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>Arm 1 | Procedure: Intravitreal injection<br>* Intravitreal injection to the regimen pro re nata.<br>* Other names: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.;|
| Active Comparator: Aflibercept<br>Arm 2 | Procedure: Intravitreal injection<br>* Intravitreal injection to the regimen pro re nata.<br>* Other names: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) | A negative number indicates improvement (reduced thickness). | Baseline-Month 12 | 
| Average Number of Intravitreal Injections | The number of intravitreal injections administered | Baseline-Month 12 | 
| Number of Endophthalmitis after Intravitreal Injections | The number of endophthalmitis registered in patients after intravitreal injections | Baseline-Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fundus diseases, antiangiogenic therapy, choroidal neovascularization, pathologyc myopia, intravitreal injection, anti-VEGF