Clinical trial NCT02976194: Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy
Official title: Intraocular Cytokine Changes in Recurrence of Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Exudative Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2016-11-29
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.

Detailed description: PCV is regarded as a subtype of age-related macular degeneration (ARMD), but has several different features such as polypoidal terminal of new vessels, and relative resistance to anti-VEGF treatment. Other cytokines then VEGF are thought to be associated with development and progression of the disease. The aim of the this study is to investigate intraocular cytokines related to recurrence of polypoidal choroidal vasculopathy. Aqueous humor will be sampled from the anterior chamber at baseline, after loading injections of ranibizumab and at recurrence. The concentration of various cytokines will be measured in the aqueous humor.

Eligibility criteria: Inclusion Criteria:

1. Submacular PCV diagnosed based on branching neovascular networks having polypoidal dilatation in ICGA.
2. Presence of exudative changes involving the fovea in OCT
3. Decreased visual acuity to 20/320 - 20/40 to be primarily the results of PCV in the study eye.
4. Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.

Exclusion Criteria:

1. Extramacular PCV.
2. Presence of pathologic changes blocking 50% or more area of the lesion in angiography.
3. Any anti-VEGF treatment in the study eye within 180 days of day 1.
4. Previous photodynamic therapy in the study eye.
5. History of intraocular surgery except uncomplicated cataract surgery performed before 90 days or more from day 1.
6. Presence of exudative ARMD requiring anti-VEGF treatment in the other eye.
7. Presence of other ocular disease that may compromise visual acuity in the study eye.
8. Uncontrolled systemic disease.
9. Active intraocular or periocular infection.
10. Active intraocular inflammation.
11. Hypersensitivity to ranibizumab or excipients.

Primary outcomes:
measure: Changes of VEGF-A from 8 weeks to 20 weeks
timeFrame: 8 weeks and 20 weeks
Secondary outcomes:
measure: Changes of the other cytokines from 8 weeks to 20 weeks
timeFrame: 8 weeks and 20 weeks
measure: Changes of cytokines from baseline to 8 weeks
timeFrame: baseline and 8 weeks
measure: Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks.
timeFrame: baseline and 8 weeks
measure: Correlation between vision changes and cytokine concentration changes
timeFrame: baseline and 24 weeks.
measure: Correlation between CSMT and cytokine concentration
timeFrame: baseline, 8 weeks and 20 weeks.
measure: Correlation between choroidal thickness and cytokine concentration
timeFrame: baseline, 8 weeks and 20 weeks.
measure: Correlation between area of new vessels and cytokine concentration
timeFrame: baseline
measure: Correlation between polyp closure and cytokine concentration changes
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Ji Eun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cha DM, Woo SJ, Kim HJ, Lee C, Park KH. Comparative analysis of aqueous humor cytokine levels between patients with exudative age-related macular degeneration and normal controls. Invest Ophthalmol Vis Sci. 2013 Oct 25;54(10):7038-44. doi: 10.1167/iovs.13-12730.
citation: Rezar-Dreindl S, Sacu S, Eibenberger K, Pollreisz A, Buhl W, Georgopoulos M, Krall C, Weigert G, Schmidt-Erfurth U. The Intraocular Cytokine Profile and Therapeutic Response in Persistent Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2016 Aug 1;57(10):4144-50. doi: 10.1167/iovs.16-19772.
citation: Hu J, Leng X, Hu Y, Atik A, Song X, Li Z, Liu Y, Lu L. The Features of Inflammation Factors Concentrations in Aqueous Humor of Polypoidal Choroidal Vasculopathy. PLoS One. 2016 Jan 22;11(1):e0147346. doi: 10.1371/journal.pone.0147346. eCollection 2016.
citation: Sakurada Y, Nakamura Y, Yoneyama S, Mabuchi F, Gotoh T, Tateno Y, Sugiyama A, Kubota T, Iijima H. Aqueous humor cytokine levels in patients with polypoidal choroidal vasculopathy and neovascular age-related macular degeneration. Ophthalmic Res. 2015;53(1):2-7. doi: 10.1159/000365487. Epub 2014 Nov 29.
citation: Tong JP, Chan WM, Liu DT, Lai TY, Choy KW, Pang CP, Lam DS. Aqueous humor levels of vascular endothelial growth factor and pigment epithelium-derived factor in polypoidal choroidal vasculopathy and choroidal neovascularization. Am J Ophthalmol. 2006 Mar;141(3):456-62. doi: 10.1016/j.ajo.2005.10.012.