Initial Versus Delayed PDT Combination With Conbercept in PCV

NCT02821520 | Completed Phase 4 DMC

• 1 other identifier: Y-2016020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal Vasculopathy; Photodynamic Therapy; Conbercept; Efficacy; Safety; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity (BCVA) in each group,Compare the difference between the two groups.

  from baseline (month 0) to month 12

Secondary Outcomes (7)

• The proportion of polyps regression assessed by ICGA in each group.Compare the difference between the two groups.

  from Baseline (month 0) to month 12

• Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT)

  from Baseline baseline (month 0) to month 12

• Total number of treatments with PDT and conbercept respectively

  from Baseline (month 0) to month 12

• Change in Best Corrected Visual Acuity (BCVA) at month 3

  from Baseline baseline (month 0) to month 3

• Polyps regression, assessed by Indocyanine Green Angiography (ICGA)

  from baseline (month 0) to month 3

Study Arms (2)

Initial PDT combination with Conbercept

EXPERIMENTAL

1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 2. PDT: PDT with verteporfin is administered at baseline and then PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11. PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT. PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months.

Drug: conbercept; Procedure: Initial PDT

Delayed PDT combination with Conbercept

ACTIVE COMPARATOR

1. Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 2. PDT:PRN PDT combination with conbercept injection based on retreatment criteria from month 3 to 11. PDT treatment must be administered within 7 days after the injection. If same day treatment of conbercept and PDT is performed, conbercept injection is to be administered at least 2 hours after the PDT. PDT should cover the whole area of polyps and branch vascular net (BVN).The PRN PDT retreatment intervals should be no less than 3 months.

Drug: conbercept; Procedure: Delayed PDT

Interventions

conbercept DRUG

At baseline conbercept injection is administered.And thereafter is administered based on re-treatment criteria from month 1 to 11.The PRN conbercept re-injection should be monthly.

Also known as: lumitin

Delayed PDT combination with Conbercept; Initial PDT combination with Conbercept

Initial PDT PROCEDURE

At baseline PDT with verteporfin is administered initially.And thereafter PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.

Also known as: verteporfin

Initial PDT combination with Conbercept

Delayed PDT PROCEDURE

PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.

Also known as: verteporfin

Delayed PDT combination with Conbercept

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either gender，age ≥ 40.
• BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).
• Naive symptomatic PCV patients.
• Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.
• No refractive media opacity or small pupil narrow that influence the fundus examination.
• Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.
• Ability to provide written informed consent and to return for all study visits.

You may not qualify if:

• Active inflammation or infection in the study eye.
• Uncontrolled intraocular pressure (\>25 mmHg) in the study eye.
• Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
• Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
• Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
• Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
• Allergy to fluorescein, ICG, iodine, shellfish.
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• The Eye Hospital of Wenzhou Medical University: lead

Study Sites (3)

The first affiliated hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (13)

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• Ciardella AP, Donsoff IM, Huang SJ, Costa DL, Yannuzzi LA. Polypoidal choroidal vasculopathy. Surv Ophthalmol. 2004 Jan-Feb;49(1):25-37. doi: 10.1016/j.survophthal.2003.10.007.

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• Imamura Y, Engelbert M, Iida T, Freund KB, Yannuzzi LA. Polypoidal choroidal vasculopathy: a review. Surv Ophthalmol. 2010 Nov-Dec;55(6):501-15. doi: 10.1016/j.survophthal.2010.03.004. Epub 2010 Sep 20.

  PMID: 20850857 BACKGROUND

• Gomi F, Tano Y. Polypoidal choroidal vasculopathy and treatments. Curr Opin Ophthalmol. 2008 May;19(3):208-12. doi: 10.1097/ICU.0b013e3282fb7c33.

  PMID: 18408495 BACKGROUND

• Laude A, Cackett PD, Vithana EN, Yeo IY, Wong D, Koh AH, Wong TY, Aung T. Polypoidal choroidal vasculopathy and neovascular age-related macular degeneration: same or different disease? Prog Retin Eye Res. 2010 Jan;29(1):19-29. doi: 10.1016/j.preteyeres.2009.10.001. Epub 2009 Oct 23.

  PMID: 19854291 BACKGROUND

• Koh AH; Expert PCV Panel; Chen LJ, Chen SJ, Chen Y, Giridhar A, Iida T, Kim H, Yuk Yau Lai T, Lee WK, Li X, Han Lim T, Ruamviboonsuk P, Sharma T, Tang S, Yuzawa M. Polypoidal choroidal vasculopathy: evidence-based guidelines for clinical diagnosis and treatment. Retina. 2013 Apr;33(4):686-716. doi: 10.1097/IAE.0b013e3182852446.

  PMID: 23455233 BACKGROUND

• Qu J, Cheng Y, Li X, Yu L, Ke X; AURORA Study Group. EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study. Retina. 2016 May;36(5):926-37. doi: 10.1097/IAE.0000000000000875.

  PMID: 26595362 BACKGROUND

• Gomi F, Oshima Y, Mori R, Kano M, Saito M, Yamashita A, Iwata E, Maruko R; Fujisan Study Group. INITIAL VERSUS DELAYED PHOTODYNAMIC THERAPY IN COMBINATION WITH RANIBIZUMAB FOR TREATMENT OF POLYPOIDAL CHOROIDAL VASCULOPATHY: The Fujisan Study. Retina. 2015 Aug;35(8):1569-76. doi: 10.1097/IAE.0000000000000526.

  PMID: 25830698 BACKGROUND

• Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.

  PMID: 22426346 BACKGROUND

• Oishi A, Kojima H, Mandai M, Honda S, Matsuoka T, Oh H, Kita M, Nagai T, Fujihara M, Bessho N, Uenishi M, Kurimoto Y, Negi A. Comparison of the effect of ranibizumab and verteporfin for polypoidal choroidal vasculopathy: 12-month LAPTOP study results. Am J Ophthalmol. 2013 Oct;156(4):644-51. doi: 10.1016/j.ajo.2013.05.024. Epub 2013 Jul 20.

  PMID: 23876867 BACKGROUND

• Sun Z, Gong Y, Yang Y, Huang Y, Yu S, Pei J, Lin B, Zhou R, Li Y, Li Y, Zhang J, Liu X. Efficacy of Initial vs. Delayed Photodynamic Therapy in Combination With Conbercept for Polypoidal Choroidal Vasculopathy. Front Med (Lausanne). 2022 Feb 9;8:791935. doi: 10.3389/fmed.2021.791935. eCollection 2021.

  PMID: 35223882 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

KH902 fusion protein; Verteporfin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Xiaoling Liu, Professor

  The Eye Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: July 1, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

CN (3)