Cytokeratin 8 Level in Age-related Macular Degeneration

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02707575

Enrollment

Registered

2016-03-14

Start date

2016-04-26

Completion date

2018-04-23

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

Keratin, Ranibizumab

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.

Interventions

DRUGRanibizumab

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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	The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026