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| Name | Class |
|---|---|
| Konkuk University | OTHER |
| Inje University | OTHER |
| Novartis | INDUSTRY |
| Severance Hospital |
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The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.
In this non-randomized, and open-label study, the investigators will prospectively evaluate 58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual (the best corrected visual acuity change) and anatomical (optical coherence tomography parameters) after Ranibizumab injection will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Intravitreal Ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Three monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity | The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity | From baseline to one month after three monthly consecutive ranibizumab injection |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT) | The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT) | From baseline to one month after three monthly consecutive ranibizumab injection |
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Inclusion Criteria:
Exclusion Criteria:
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Included patient is required to be least 50 years of age with newly diagnosed exudative age-related macular degeneration, with a recent onset of disease.
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| Name | Affiliation | Role |
|---|---|---|
| Suk Ho Byeon, MD. Ph.D. | Professor. Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Ilsan Paik Hospital | Goyang | South Korea | ||||
| Gangnam Severance Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2020 | Dec 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Aqueous humor
|
| Seoul |
| South Korea |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |