Initial Versus Delayed PDT Combination With Conbercept in PCV

July 17, 2019 updated by: Xiaoling Liu, The Eye Hospital of Wenzhou Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • The first affiliated hospital of Shanghai Jiaotong University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
      • Wenzhou, Zhejiang, China, 325000
        • The Eye Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Active inflammation or infection in the study eye.
  2. Uncontrolled intraocular pressure (>25 mmHg) in the study eye.
  3. 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).
  4. Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
  5. 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.
  6. Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
  7. Allergy to fluorescein, ICG, iodine, shellfish.
  8. Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial PDT combination with Conbercept
  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
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
Procedure: Initial PDT
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
Active Comparator: Delayed PDT combination with Conbercept
  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
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
Procedure: Delayed PDT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
from baseline (month 0) to month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from Baseline (month 0) to month 12
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
from Baseline baseline (month 0) to month 12
Total number of treatments with PDT and conbercept respectively
Time Frame: from Baseline (month 0) to month 12
from Baseline (month 0) to month 12
Change in Best Corrected Visual Acuity (BCVA) at month 3
Time Frame: from Baseline baseline (month 0) to month 3
from Baseline baseline (month 0) to month 3
Polyps regression, assessed by Indocyanine Green Angiography (ICGA)
Time Frame: from baseline (month 0) to month 3
from baseline (month 0) to month 3
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
from baseline (month 0) to month 3
Frequency and severity of ocular and non-ocular adverse events over time.
Time Frame: from baseline (month 0) to month 12
from baseline (month 0) to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Eye Hospital of Wenzhou Medical University

Investigators

  • Principal Investigator: Xiaoling Liu, Professor, The Eye Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

June 25, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-2016020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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