Cytokeratin 8 Level in Age-related Macular Degeneration

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: Ranibizumab

• Registration Number: NCT02707575
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Study Start: 2016-04-26
• Primary Completion: 2018-03-12
• Study Completion: 2018-04-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-05
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	Intravitreal Ranibizumab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of