Cytokeratin 8 Level in Age-related Macular Degeneration

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Age-related Macular Degeneration

Treatments: Drug: Ranibizumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02707575

3-2015-0304

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 58 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

58 participants in 1 patient group

Ranibizumab

Description:

Intravitreal Ranibizumab

Treatment:

Drug: Ranibizumab