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OpenTrials
Completed

NCT Number: NCT02707575

Cytokeratin 8 Level in 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.

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Key information

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University Ilsan Paik Hospital, Goyang, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
  • A recent onset of disease confirmed by history and clinical findings.
  • Patient is required to be least 50 years of age

Exclusion criteria

  • Myopia with a refractive error >-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
  • Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
  • History of cataract surgery within 3 months prior to presentation
  • Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
  • Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
  • Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location

Treatment and study plan

ranibizumab

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.

Other names: Lucentis

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Collaborators

  • Inje University
  • Konkuk University
  • Novartis
  • Severance Hospital

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2016
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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