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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 and safety of triamcinolone acetonide in patients with serous pigment detachment associated with age-related macular degeneration
The purpose of this study is to determine the effectiveness and safety of triamcinolone acetonide in patients with serous pigment epithelial detachment associated with age-related macular degeneration.
This study is planned as a follow-up. Patients with with serous pigment epithelial detachment associated with age-related macular degeneration included in it will receive triamcinolone acetonide 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 |
|---|---|---|---|
| Triamcinolone Acetonide 40 mg | Active Comparator | Arm 1 |
|
| Triamcinolone Acetonide 4 mg | Active Comparator | Arm 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtenon injection of 40 mg triamcinolone acetonide | Procedure | Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination. |
| 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 |
|---|---|---|
| Number of Flattened Pigment Epithelial Detachment | Number of flattened pigment epithelial detachment | Baseline-Month 12 |
| Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Odessa National Medical University | Odesa | Please Select | 65061 | Ukraine | ||
| CPUkraine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24600628 | Background | V Pasyechnikova N, A Naumenko V, R Korol A, S Zadorozhnyy O, B Kustrin T, O Nasinnyk I. Serous pigment epithelium detachment associated with age-related macular degeneration: a possible treatment approach. Med Hypothesis Discov Innov Ophthalmol. 2012 Winter;1(4):72-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2022 | |
| Reset | Sep 5, 2023 |
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| Intravitreal injection of 4 mg triamcinolone acetonide | Procedure | Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination. |
|
| Visometry | Diagnostic Test | Ophthalmic examination |
|
| Fluorescent angiography | 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 |
|
| IOP | Diagnostic Test | Ophthalmic examination |
|
A negative number indicates improvement (reduced thickness).
| Baseline-Month 12 |
| Average Number of Injections | The number of injections administered | Baseline-Month 12 |
| Intraocular pressure | The difference between intraocular pressure at baseline and at Month 12 | Baseline-Month 12 |
| Kyiv |
| Ukraine |
| Mykolaiv Region Ophthalmogical Hospital | Mykolaiv | 54000 | Ukraine |
| The Filatov Institute of Eye Diseases and Tissue Therapy | Odesa | 65061 | Ukraine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2022 | Sep 5, 2023 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D005451 | Fluorescein Angiography |
| D000072776 | Slit Lamp Microscopy |
| D009887 | Ophthalmoscopy |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003941 | Diagnostic Techniques, Ophthalmological |
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