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| Name | Class |
|---|---|
| Odessa National Medical University | OTHER |
| Mykolaiv Region Ophthalmogical Hospital | OTHER |
| Central Polyclinic of Internal Affairs of Ukraine | OTHER_GOV |
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The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to pathologic myopia.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Active Comparator | Arm 1 |
|
| Aflibercept | Active Comparator | Arm 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection | Procedure | Intravitreal injection to the regimen pro re nata. |
|
| 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 |
| 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 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Andrii MD Korol, PhD | The Filatov Institute of Eye Diseases and Tissue Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mykolaiv Region Ophthalmogical Hospital | Mykolaiv | 54000 | Ukraine | |||
| Odessa National Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27853350 | Background | 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. |
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| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
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| ID | Term |
|---|---|
| D058449 | Intravitreal Injections |
| D012031 | Refractometry |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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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 |
| Odesa |
| 65028 |
| Ukraine |
| The Filatov Institute of Eye Diseases and Tissue Therapy | Odesa | 65061 | Ukraine |
| D008679 |
| Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |