Choroidal Neovascularization Clinical Trial
Official title:
Polypoidal Choroidal Vasculopathy in Pachychoroid: Aflibercept + PDT Combined Therapy
Verified date | August 2019 |
Source | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate patients with diagnosis of polypoidal choroidal vasculopathy (PCV) in pachychoroid treated with combined therapy, consisting in photodynamic therapy (PDT) and 3 intravitreal therapy (IVT) of Aflibercept monthly. This is a single center, prospective case-series study. The investigators are going to evaluate Corrected Distance Visual Acuity (CDVA), disease activity, retinal and choroidal thicknesses and number of injection per year, during a twelve month follow up. The aim of this study is to verify if the combined therapy can act on the insult induced by the pachychoroid and on the neovascular lesion itself in this sub-population of patients with PCV in pachychoroid,
Status | Completed |
Enrollment | 17 |
Est. completion date | July 13, 2019 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - presence of haemorrhagic or exudative PCV diagnosed by OCT and ICGA - Mean central choroidal thickness > 250 µm Exclusion Criteria: - ocular comorbidity - previous cardiovascular events - different ocular surgical procedures form cataract surgery |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
Italy,
Balaratnasingam C, Lee WK, Koizumi H, Dansingani K, Inoue M, Freund KB. Polypoidal Choroidal Vasculopathy: A Distinct Disease or Manifestation of Many? Retina. 2016 Jan;36(1):1-8. doi: 10.1097/IAE.0000000000000774. — View Citation
Koh A, Lai TYY, Takahashi K, Wong TY, Chen LJ, Ruamviboonsuk P, Tan CS, Feller C, Margaron P, Lim TH, Lee WK; EVEREST II study group. Efficacy and Safety of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1206-1213. doi: 10.1001/jamaophthalmol.2017.4030. — View Citation
Pang CE, Freund KB. Pachychoroid neovasculopathy. Retina. 2015 Jan;35(1):1-9. doi: 10.1097/IAE.0000000000000331. — View Citation
Wong TY, Ogura Y, Lee WK, Iida T, Chen SJ, Mitchell P, Gemmy Cheung CM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy: Two-Year Results of the Aflibercept in Polypoidal Choroidal Vasculopathy Study. Am J Ophthalmol. 2019 Aug;204:80-89. doi: 10.1016/j.ajo.2019.02.027. Epub 2019 Mar 6. — View Citation
Yanagi Y, Ting DSW, Ng WY, Lee SY, Mathur R, Chan CM, Yeo I, Wong TY, Cheung GCM. CHOROIDAL VASCULAR HYPERPERMEABILITY AS A PREDICTOR OF TREATMENT RESPONSE FOR POLYPOIDAL CHOROIDAL VASCULOPATHY. Retina. 2018 Aug;38(8):1509-1517. doi: 10.1097/IAE.0000000000001758. — View Citation
Yuzawa M, Mori R, Kawamura A. The origins of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2005 May;89(5):602-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corrected Distance Visual Acuity | measured in logMAR notation using Early Treatment of Diabetic Retinopathy Study charts (CC-100XP LCD System for ETDRS Chart display) | twelve months | |
Primary | Disease Activity | measured as percentage of patients with subretinal or intraretinal fluid | twelve months | |
Primary | Retinal Thickness | Central retinal thickness (1 mm central foveal thickness) and mean macular thickness (second and the third 6-mm grid including parafoveal and perifoveal macular area) | twelve months | |
Primary | Choroidal thickness | Central choroidal thickness (1 mm central subfoveal thickness) and mean choroideal thickness (second and the third 6-mm grid including parafoveal and perifoveal choroidal area) | twelve months | |
Secondary | Number of injections per year | Number of intravitreal injection administered in a year | twelve months |
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