Cytokeratin 8 Level in Age-related Macular Degeneration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cytokeratin 8 Level in Aqueous Humor, as a Prognostic Factor for Visual and Anatomical Outcomes After Ranibizumab (Lucentis) in Neovascular Age-related Macular Degeneration

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab A recent onset of disease confirmed by history and clinical findings. Patient is required to be least 50 years of age Exclusion Criteria: Myopia with a refractive error >-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes) Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT) History of cataract surgery within 3 months prior to presentation Evidence of end-stage AMD such as subfoveal fibrosis or atrophy Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ranibizumab<br>Intravitreal Ranibizumab | Drug: Ranibizumab<br>* 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.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratin, Ranibizumab