Cytokeratin 8 Level in Age-related Macular Degeneration

Gangnam Severance Hospital58 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Age-related Macular Degeneration

Interventions

RanibizumabDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab 2. A recent onset of disease confirmed by history and clinical findings. 3. Patient is required to be least 50 years of age Exclusion Criteria: 1. Myopia with a refractive error \>-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes) 2. Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT) 3. History of cataract surgery within 3 months prior to presentation 4. Evidence of end-stage AMD such as subfoveal fibrosis or atrophy 5. Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation 6. Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location

Locations (2)

Inje University Ilsan Paik Hospital

Goyang, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity

Time frame: From baseline to one month after three monthly consecutive ranibizumab injection

Secondary Outcomes

The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)

Time frame: From baseline to one month after three monthly consecutive ranibizumab injection

Data from ClinicalTrials.gov

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