Polypoidal Choroidal Vasculopathy Clinical Trial
— CyPovOfficial title:
Intraocular Cytokine Changes in Recurrence of Polypoidal Choroidal Vasculopathy
Verified date | October 2019 |
Source | Pusan National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Changes of intraocular cytokines including vascular endothelial growth factor (VEGF) will be measured in recurrence of polypoidal choroidal vasculopathy (PCV) during treatment of ranibizumab.
Status | Active, not recruiting |
Enrollment | 28 |
Est. completion date | January 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do |
Lead Sponsor | Collaborator |
---|---|
Pusan National University Hospital | Novartis |
Korea, Republic of,
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. — View 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. — View Citation
Rezar-Dreindl S, Sacu S, Eibenberger K, Pollreisz A, Bühl 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of VEGF-A from 8 weeks to 20 weeks | Intraocular concentration of VEGF-A is measured using multiplex immunoassay. | 8 weeks and 20 weeks | |
Secondary | Changes of the other cytokines from 8 weeks to 20 weeks | Intraocular concentration of the other cytokines including angiopoietin-1, interleukin-10 (IL-10), platelet-derived growth factor (PDGF) and placental growth factor (PlGF) is measured using multiplex immunoassay. | 8 weeks and 20 weeks | |
Secondary | Changes of cytokines from baseline to 8 weeks | Intraocular concentration of cytokines including VEGF, angiopoietin-1, IL-10, PDGF and PlGF is measured using multiplex immunoassay. | baseline and 8 weeks | |
Secondary | Correlation between time to recurrence and cytokine concentration at baseline and 8 weeks. | Time to recurrence is defined as number of weeks from 8 to recurrence. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation. | baseline and 8 weeks | |
Secondary | Correlation between vision changes and cytokine concentration changes | Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher score represents better functioning. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation. | baseline and 24 weeks. | |
Secondary | Correlation between CSMT and cytokine concentration | CSMT is central 1mm thickness of the macula measured using spectral-domain optical coherence tomography (OCT). Normal thickness is around 250µm. Increased CSMT is regarded as increase of en exudative sign. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation. | baseline, 8 weeks and 20 weeks. | |
Secondary | Correlation between choroidal thickness and cytokine concentration | Choroidal thickness is thickness of the choroid measured at the foveal center using spectral-domain OCT. Increased choroidal thickness was reported to be related to poor response to anti-VEGF treatment. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation. | baseline, 8 weeks and 20 weeks. | |
Secondary | Correlation between area of new vessels and cytokine concentration | Area of new vessels is measured in indocyanine green angiography (ICGA) obtained at baseline. The correlation is assessed using non-parametric analysis, or Spearman's ranked correlation. | baseline | |
Secondary | Correlation between polyp closure and cytokine concentration changes | Polyp closure is defined as disappearance of polypoidal terminal in new vessels assessed in ICGA at 8 weeks. The difference of cytokine concentration is assessed between the closed group and un-closed group using non-parametric analysis, or Mann-Whitney U test. | baseline and 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Active, not recruiting |
NCT01950741 -
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Completed |
NCT01469156 -
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT02597855 -
Comparison of the Short-term Outcomes of Intravitreal Aflibercept Injection Between Two Subtypes of Polypoidal Choroidal Vasculopathy Using Indocyanine Green Angiography
|
N/A | |
Completed |
NCT02495181 -
Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Recruiting |
NCT01248117 -
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Completed |
NCT01884597 -
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04707027 -
Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept
|
N/A | |
Recruiting |
NCT02141308 -
OCT in Rare Chorioretinal Diseases
|
||
Completed |
NCT01871376 -
Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
|
Phase 4 | |
Completed |
NCT00470977 -
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT00383812 -
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
|
N/A | |
Completed |
NCT00837330 -
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Completed |
NCT05229237 -
Conbercept for Polypoidal Choroidal Vasculopathy(START Study)
|
||
Not yet recruiting |
NCT04380974 -
Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Recruiting |
NCT02815176 -
Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers
|
N/A | |
Active, not recruiting |
NCT00344617 -
Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy
|
Phase 3 | |
Recruiting |
NCT03929731 -
Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy (PCV)
|
||
Completed |
NCT01023295 -
Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
|
Phase 2 | |
Completed |
NCT02821520 -
Initial Versus Delayed PDT Combination With Conbercept in PCV
|
Phase 4 |