Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy

NCT04380974 | Unknown Phase 4

• 1 other identifier: PCV20200506
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the efficacy and safety of two different regimens of anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal Vasculopathy; Optical coherence tomography angiography; Optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• PCV lesion recurrence

  PCV lesion recurrence is defined as the reappearance of new exudative biomakers (such as IRF, SRF, PED) or new hemorrhage detected on OCT or fundus examination in subsequent visits from the last visit showing clinical stability. PCV lesion recurrence rate will be compared at 24months between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.

  24 months

Secondary Outcomes (4)

• Mean Snellen BCVA at every visit or treatment

  24 months

• Number of participants with treatment-related adverse events

  24 months

• Mean number of injections after the initial three loading dose monthly injections

  21 months

• Mean central macular thickness at every visit or treatment by OCT

  24 months

Study Arms (2)

OCTA plus OCT guided 3+PRN regimen

EXPERIMENTAL

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.

Procedure: OCTA plus OCT guided 3+PRN regimen; Drug: Anti-VEGF drug

OCT guided 3+PRN regimen

ACTIVE COMPARATOR

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.

Procedure: OCT guided 3+PRN regimen; Drug: Anti-VEGF drug

Interventions

OCTA plus OCT guided 3+PRN regimen PROCEDURE

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.

OCTA plus OCT guided 3+PRN regimen

OCT guided 3+PRN regimen PROCEDURE

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.

OCT guided 3+PRN regimen

Anti-VEGF drug DRUG

Conbercept or other anti-VEGF drugs

OCT guided 3+PRN regimen; OCTA plus OCT guided 3+PRN regimen

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed-consent before any evaluation
• Visual impairment due to PCV, including type 1 PCV and type 2 PCV.
• 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.

You may not qualify if:

• Have Stroke and myocardial infarction within 3 months before screening
• 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:
• Anti-angiogenesis drugs (pegaptanib, ranibizumab, bevacizumab),VEGF-Trap;
• Anecortave acetate corticosteroids;
• Protein kinase C inhibitors, squalamine, siRNA;
• 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

Sponsors & Collaborators

• Xiaodong Sun: lead
• Eye & ENT Hospital of Fudan University: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Location

Related Publications (13)

• Yannuzzi LA, Sorenson J, Spaide RF, Lipson B. Idiopathic polypoidal choroidal vasculopathy (IPCV). 1990. Retina. 2012 Feb;32 Suppl 1:1-8.

  PMID: 22451948 BACKGROUND

• 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.

  PMID: 29331556 BACKGROUND

• 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.

  PMID: 27094371 BACKGROUND

• 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.

  PMID: 22990319 BACKGROUND

• 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.

  PMID: 23769197 BACKGROUND

• 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.

  PMID: 24978485 BACKGROUND

• 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.

  PMID: 22465366 BACKGROUND

• 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.

  PMID: 23428984 BACKGROUND

• 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.

  PMID: 23891333 BACKGROUND

• 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.

  PMID: 26405770 BACKGROUND

• 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.

  PMID: 27472276 BACKGROUND

• 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.

  PMID: 28613216 BACKGROUND

• 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.

  PMID: 30998817 BACKGROUND

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaodong Sun

  Shanghai General Hospital, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Sun

CONTACT

+86-02163240090; xdsun@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Executive Vicechair of Department of Ophthalmology

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 8, 2020
• Study Start: June 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: September 1, 2022
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

CN (1)