Cytokeratin 8 Level in Age-related Macular Degeneration

December 5, 2020 updated by: Suk Ho Byeon, Gangnam Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ranibizumab
Intravitreal Ranibizumab
Drug: Ranibizumab
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.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 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)
From baseline to one month after three monthly consecutive ranibizumab injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Collaborators

Novartis
Inje University
Severance Hospital
Konkuk University

Investigators

  • Principal Investigator: Suk Ho Byeon, MD. Ph.D., Professor. Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2016

Primary Completion (Actual)

March 12, 2018

Study Completion (Actual)

April 23, 2018

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 5, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2015-0304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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