Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
NCT ID: NCT04380974
Last Updated: 2020-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
102 participants
INTERVENTIONAL
2020-06-30
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OCTA plus OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization, OCTA and OCT in the extension treatment period.
OCTA plus OCT guided 3+PRN regimen
For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT.
In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
Anti-VEGF drug
Conbercept or other anti-VEGF drugs
OCT guided 3+PRN regimen
Monthly intravitreal injections of anti-VEGF drug in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization and OCT in the extension treatment period.
OCT guided 3+PRN regimen
For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, and OCT.
In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
Anti-VEGF drug
Conbercept or other anti-VEGF drugs
Interventions
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OCTA plus OCT guided 3+PRN regimen
For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT.
In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
OCT guided 3+PRN regimen
For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, and OCT.
In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
Anti-VEGF drug
Conbercept or other anti-VEGF drugs
Eligibility Criteria
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Inclusion Criteria
* Visual impairment due to PCV, including type 1 PCV and type 2 PCV.
* 50 years old and older
* Chinese
* For study eye: BCVA between 20/30 and 20/320 on electronic visual acuity texting at the time point of both screening and baseline.
Exclusion Criteria
* Any active periocular and ocular infection and inflammation (including blepharitis, conjunctivitis, keratitis, scleritis, uveitis, intraocular inflammation) while screening and baseline.
* Uncontrolled glaucoma (under treatment \[IOP\] ≥ 30 mm Hg or depend on researchers) while screening and baseline
* Neovascularization of iris and neovascular glaucoma while screening and baseline
* Any causes led to choroidal neovascularization except PCV (including ICNV, central serous chorioretinopathy, ocular histoplazmoza and pathologic myopia) while screening and baseline
* With structure injury (including vitreous macular traction,epiretinal membrane involving in central fovea,subretinal fibroplasia,laser scar and central fovea atrophy) within 0.5 optic disc diameter to the central of macula while screening and baseline, which may harm the improvement of vision by treatment according to researchers
* Any systemic anti-VEGF medication(as Avastin) use within 3 months before screening
* Any medication systemic use toxic to lens, retina and optic nerve, including iron amine, chloroquine/chloroquine (Plaquenil ®), tamoxifen, phenothiazine and ethambutol
* For study eye: Used to accept following treatments for PCV within 3 months or accept following treatments more than three times before baseline:
1. Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap;
2. Anecortave acetate corticosteroids;
3. Protein kinase C inhibitors, squalamine, siRNA;
4. PDT, Visudyne® treatment, external beam radiotherapy, local laser photocoagulation, vitrectomy, submacular surgery and transpupillary thermotherapy
* Any intraocular surgery (including YAG laser) within 3 months before baseline or predicated within 6 months after baseline
* Intraocular or periocular treatment of corticosteroids within 3 months before baseline
* For follow eye: Any anti-angiogenesis treatment (including anti-VEGF, like Lucentis, Avastin and KH902 ) within 3 months before baseline
50 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Shanghai Zhongshan Hospital
OTHER
Xiaodong Sun
OTHER
Responsible Party
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Xiaodong Sun
Professor and Executive Vicechair of Department of Ophthalmology
Principal Investigators
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Xiaodong Sun
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University
Locations
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Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaodong Sun
Role: primary
References
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Yannuzzi LA, Sorenson J, Spaide RF, Lipson B. Idiopathic polypoidal choroidal vasculopathy (IPCV). 1990. Retina. 2012 Feb;32 Suppl 1:1-8.
Cheung CMG, Lai TYY, Ruamviboonsuk P, Chen SJ, Chen Y, Freund KB, Gomi F, Koh AH, Lee WK, Wong TY. Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management. Ophthalmology. 2018 May;125(5):708-724. doi: 10.1016/j.ophtha.2017.11.019. Epub 2018 Jan 10.
Wong CW, Yanagi Y, Lee WK, Ogura Y, Yeo I, Wong TY, Cheung CMG. Age-related macular degeneration and polypoidal choroidal vasculopathy in Asians. Prog Retin Eye Res. 2016 Jul;53:107-139. doi: 10.1016/j.preteyeres.2016.04.002. Epub 2016 Apr 14.
Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0.
Cho HJ, Koh KM, Kim HS, Lee TG, Kim CG, Kim JW. Anti-vascular endothelial growth factor monotherapy in the treatment of submacular hemorrhage secondary to polypoidal choroidal vasculopathy. Am J Ophthalmol. 2013 Sep;156(3):524-531.e1. doi: 10.1016/j.ajo.2013.04.029. Epub 2013 Jun 13.
Cheung CM, Li X, Mathur R, Lee SY, Chan CM, Yeo I, Loh BK, Williams R, Wong EY, Wong D, Wong TY. A prospective study of treatment patterns and 1-year outcome of Asian age-related macular degeneration and polypoidal choroidal vasculopathy. PLoS One. 2014 Jun 30;9(6):e101057. doi: 10.1371/journal.pone.0101057. eCollection 2014.
Hikichi T, Higuchi M, Matsushita T, Kosaka S, Matsushita R, Takami K, Ohtsuka H, Ariga H. One-year results of three monthly ranibizumab injections and as-needed reinjections for polypoidal choroidal vasculopathy in Japanese patients. Am J Ophthalmol. 2012 Jul;154(1):117-124.e1. doi: 10.1016/j.ajo.2011.12.019. Epub 2012 Apr 1.
Hikichi T, Higuchi M, Matsushita T, Kosaka S, Matsushita R, Takami K, Ohtsuka H, Kitamei H, Shioya S. Results of 2 years of treatment with as-needed ranibizumab reinjection for polypoidal choroidal vasculopathy. Br J Ophthalmol. 2013 May;97(5):617-21. doi: 10.1136/bjophthalmol-2012-302652. Epub 2013 Feb 21.
Kang HM, Koh HJ. Long-term visual outcome and prognostic factors after intravitreal ranibizumab injections for polypoidal choroidal vasculopathy. Am J Ophthalmol. 2013 Oct;156(4):652-60. doi: 10.1016/j.ajo.2013.05.038. Epub 2013 Jul 24.
Inoue M, Balaratnasingam C, Freund KB. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY OF POLYPOIDAL CHOROIDAL VASCULOPATHY AND POLYPOIDAL CHOROIDAL NEOVASCULARIZATION. Retina. 2015 Nov;35(11):2265-74. doi: 10.1097/IAE.0000000000000777.
Wang M, Zhou Y, Gao SS, Liu W, Huang Y, Huang D, Jia Y. Evaluating Polypoidal Choroidal Vasculopathy With Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT526-32. doi: 10.1167/iovs.15-18955.
Chan SY, Wang Q, Wang YX, Shi XH, Jonas JB, Wei WB. POLYPOIDAL CHOROIDAL VASCULOPATHY UPON OPTICAL COHERENCE TOMOGRAPHIC ANGIOGRAPHY. Retina. 2018 Jun;38(6):1187-1194. doi: 10.1097/IAE.0000000000001702.
Bo Q, Yan Q, Shen M, Song M, Sun M, Yu Y, Rosenfeld PJ, Wang F, Sun X. Appearance of Polypoidal Lesions in Patients With Polypoidal Choroidal Vasculopathy Using Swept-Source Optical Coherence Tomographic Angiography. JAMA Ophthalmol. 2019 Jun 1;137(6):642-650. doi: 10.1001/jamaophthalmol.2019.0449.
Other Identifiers
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PCV20200506
Identifier Type: -
Identifier Source: org_study_id
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