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Initial Versus Delayed PDT Combination With Conbercept in PCV

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

conbercept

Initial PDT

Delayed PDT

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring Polypoidal Choroidal Vasculopathy, Photodynamic Therapy, Conbercept, Efficacy, Safety, vascular endothelial growth factor

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial PDT combination with Conbercept

Delayed PDT combination with Conbercept

Arm Description

Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 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.

Conbercept 0.5 mg(0.05ml): Administered at baseline, and then PRN based on retreatment criteria monthly from month 1 to 11. 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Total number of treatments with PDT and conbercept respectively

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

Polyps regression, assessed by Indocyanine Green Angiography (ICGA)

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

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

Full Information

NCT ID

NCT02821520

First Posted

June 25, 2016

Last Updated

July 17, 2019

Sponsor

The Eye Hospital of Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02821520

Brief Title

Initial Versus Delayed PDT Combination With Conbercept in PCV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 2017 (undefined)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Eye Hospital of Wenzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polypoidal Choroidal Vasculopathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Initial PDT combination with Conbercept

Arm Type

Experimental

Arm Description

Arm Title

Delayed PDT combination with Conbercept

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

conbercept

Other Intervention Name(s)

lumitin

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Initial PDT

Other Intervention Name(s)

verteporfin

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Delayed PDT

Other Intervention Name(s)

verteporfin

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

Total number of treatments with PDT and conbercept respectively

Time Frame

from Baseline (month 0) to month 12

Title

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

Time Frame

from Baseline baseline (month 0) to month 3

Title

Polyps regression, assessed by Indocyanine Green Angiography (ICGA)

Time Frame

from baseline (month 0) to month 3

Title

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

Title

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

Time Frame

from baseline (month 0) to month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaoling Liu, Professor

Organizational Affiliation

The Eye Hospital of Wenzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of Shanghai Jiaotong University

City

Shanghai

State/Province

Shanghai

Country

China

Facility Name

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

City

Hangzhou

State/Province

Zhejiang

Country

China

Facility Name

The Eye Hospital of Wenzhou Medical University

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Initial Versus Delayed PDT Combination With Conbercept in PCV

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