Condition or disease | Intervention/treatment | Phase |
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Pathologic Myopia | Procedure: Intravitreal injection | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia |
Actual Study Start Date : | March 27, 2018 |
Estimated Primary Completion Date : | July 1, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Active Comparator: Ranibizumab
Arm 1
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Procedure: Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Other Name: 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
Arm 2
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Procedure: Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Other Name: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.
|
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
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Contact: Andrii MD Korol, PhD | +380936327266 | andrii.r.korol@gmail.com | |
Contact: Viktoriia MD Rostel | +380976126589 | rostelviktoria@gmail.com |
Ukraine | |
Mykolaiv Region Ophthalmogical Hospital | Recruiting |
Mykolaiv, Ukraine, 54000 | |
Contact: Krasymira Rylkovа, PhD | |
Odessa National Medical University | Recruiting |
Odessa, Ukraine, 65028 | |
Contact: Nadiia Ulianova, PhD | |
The Filatov Institute of Eye Diseases and Tissue Therapy | Recruiting |
Odessa, Ukraine, 65061 |
Principal Investigator: | Andrii MD Korol, PhD | The Filatov Institute of Eye Diseases and Tissue Therapy |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||||
First Posted Date ICMJE | May 24, 2019 | ||||||||
Last Update Posted Date | April 27, 2020 | ||||||||
Actual Study Start Date ICMJE | March 27, 2018 | ||||||||
Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart [ Time Frame: Baseline-Month 12 ] Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia | ||||||||
Official Title ICMJE | Collaborative Ocular Antiangiogenic Study of Ukraine. Multicentral, Open-label, Randomized, Prospective Study of Antiangiogenic Therapy of Choroidal Neovascularisation Associated With Myopia | ||||||||
Brief Summary | The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia. | ||||||||
Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Pathologic Myopia | ||||||||
Intervention ICMJE | Procedure: Intravitreal injection
Intravitreal injection to the regimen pro re nata.
Other Name: Patients after general ophthalmic examination (visometry, refractometry, biomicroscopy, ophthalmoscopy, OCT, fluorescence angiography) receive an injection according to the regimen pro re nata.
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Study Arms ICMJE |
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Publications * | 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. eCollection 2016. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
200 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||||||
Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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 - |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Ukraine | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03963596 | ||||||||
Other Study ID Numbers ICMJE | 0118U001612 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Andrii Korol, MD, PhD, The Filatov Institute of Eye Diseases and Tissue Therapy | ||||||||
Study Sponsor ICMJE | The Filatov Institute of Eye Diseases and Tissue Therapy | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | The Filatov Institute of Eye Diseases and Tissue Therapy | ||||||||
Verification Date | April 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |