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Completed

NCT Number: NCT02821520

Initial Versus Delayed PDT Combination With Conbercept in PCV

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The first affiliated hospital of Shanghai Jiaotong University, Shanghai, Shanghai Municipality, China

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About this study

Polypoidal choroidal vasculopathy (PCV) is characterized by polypoidal choroidal vascular dilatation with or without abnormally branching vascular networks(BVN) on indocyanine green angiography (ICGA). It has been considered to be a subtype of wet age-related macular degeneration(wAMD). PCV is more prevalent in Asian patients than in white patients; nearly half of Chinese patients who was diagnosed with wAMD actually was PCV.

However, recently, the first choice treatment for wAMD has shifted to anti-vascular endothelial growth factor (VEGF) drugs, such as bevacizumab(Avastin,Genentech Inc), ranibizumab (Lucentis, Genentech Inc)and aflibercept (Eylea, Regeneron,Berlin,Germany) from PDT, and the vision improving effect has been confirmed regardless of race or disease subtype. Therefore, eyes with PCV can be treated initially with anti-VEGF drugs, however, they are limited in their ability to resolve polypoidal lesions, for which PDT works effectively.

Combination therapy of PDT and anti-VEGF drugs provides the complementary effects of both treatments, but it remains unknown whether PDT should have been administered at the beginning of treatment or during follow-up of anti-VEGF therapy. The purpose of this study was to compare the 12-months treatment results of initial and delayed PDT combined with conbercept (Lumitin, Chengdu Kang Hong Biotech Co., Ltd., Sichuan, China) for PCV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: lumitin

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.

Other names: verteporfin

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.

Other names: verteporfin

Primary outcomes

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

    Time frame: from baseline (month 0) to month 12

Secondary outcomes

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

    Time frame: from Baseline (month 0) to month 12

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

    Time frame: from Baseline baseline (month 0) to month 12

  3. Total number of treatments with PDT and conbercept respectively

    Time frame: from Baseline (month 0) to month 12

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

    Time frame: from Baseline baseline (month 0) to month 3

  5. Polyps regression, assessed by Indocyanine Green Angiography (ICGA)

    Time frame: from baseline (month 0) to month 3

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

    Time frame: from baseline (month 0) to month 3

  7. Frequency and severity of ocular and non-ocular adverse events over time.

    Time frame: from baseline (month 0) to month 12

Sponsors and collaborators

Lead sponsor

The Eye Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Efficacy and Safety of Initial Versus Delayed Verteporfin Photodynamic Therapy in Combination With Conbercept in Patients With Symptomatic Polypoidal Choroidal Vasculopathy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2016
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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