Cytokeratin 8 Level in Age-related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707575
• Other study ID #: 3-2015-0304
• Status: Completed
• Start date: April 26, 2016
• Est. completion date: April 23, 2018

Study information

• Verified date: December 2020
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 23, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Gangnam Severance Hospital	Inje University, Konkuk University, Novartis, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity	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	The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)	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