Cytokeratin 8 Level in Age-related Macular Degeneration

NCT ID: NCT02707575

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-26

Study Completion Date

2018-04-23

Brief Summary

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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

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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.

Conditions

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Age-related Macular Degeneration

Keywords

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Keratin Ranibizumab

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Ranibizumab

Intravitreal Ranibizumab

Ranibizumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suk Ho Byeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suk Ho Byeon, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor. Yonsei University

Locations

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Inje University Ilsan Paik Hospital

Goyang, , South Korea

Site Status

Gangnam Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3-2015-0304

Identifier Type: -

Identifier Source: org_study_id