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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 central chorioretinitis.
The purpose of this study is to determine the effectiveness of antiangiogenic therapy to choroidal neovascularization secondary to central chorioretinitis.
This study is planned as a follow-up. Patients with central chorioretinitis 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.
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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 of Aflibercept 2 mg (0.05 ml) or Ranibizumab 0.5 mg (0.05 ml) 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrii MD Korol, PhD | Contact | +380936327266 | andrii.r.korol@gmail.com | |
| Viktoriia MD Rostel | Contact | +380976126589 | rostelviktoria@gmail.com |
| 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 | Recruiting | Mykolaiv | 54000 | Ukraine | ||
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|
| Fluorescent angiography | Diagnostic Test | Ophthalmic examination |
|
| Visometry | Diagnostic Test | Ophthalmic examination |
|
| Refractometry | Diagnostic Test | Ophthalmic examination |
|
| Slit lamp examination | Diagnostic Test | Ophthalmic examination |
|
| Ophthalmoscopy | Diagnostic Test | Ophthalmic examination |
|
| OKT | Diagnostic Test | Ophthalmic examination |
|
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 |
| Odessa National Medical University |
| Recruiting |
| Odesa |
| 65028 |
| Ukraine |
| The Filatov Institute of Eye Diseases and Tissue Therapy | Recruiting | Odesa | 65061 | Ukraine |
| ID | Term |
|---|---|
| D002825 | Chorioretinitis |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012173 | Retinitis |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D002833 | Choroiditis |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D015866 | Uveitis, Posterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058449 | Intravitreal Injections |
| D005451 | Fluorescein Angiography |
| D000072776 | Slit Lamp Microscopy |
| D009887 | Ophthalmoscopy |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003941 | Diagnostic Techniques, Ophthalmological |
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