Clinical trial NCT02707575: Cytokeratin 8 Level in Age-related Macular Degeneration
Official title: Cytokeratin 8 Level in Aqueous Humor, as a Prognostic Factor for Visual and Anatomical Outcomes After Ranibizumab (Lucentis) in Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Keywords: Keratin
Ranibizumab
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
Collaborators: name: Konkuk University
name: Inje University
name: Novartis
name: Severance Hospital
First posted: 2016-03-14
Enrollment: 58
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
timeFrame: From baseline to one month after three monthly consecutive ranibizumab injection
Secondary outcomes:
measure: The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)
timeFrame: From baseline to one month after three monthly consecutive ranibizumab injection
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Professor. Yonsei University
name: Suk Ho Byeon, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: