Initial Versus Delayed PDT Combination With Conbercept in PCV

Sponsor

The Eye Hospital of Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02821520

Collaborator

(none)

Enrollment

Locations

Arms

28.9

Duration (Months)

26.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Polypoidal Choroidal Vasculopathy	Drug: conbercept Procedure: Initial PDT Procedure: Delayed PDT	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Initial PDT combination with Conbercept 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.	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 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.	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

Arm

Intervention/Treatment

Experimental: Initial PDT combination with Conbercept

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.

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

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.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Change in the Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT) [from baseline (month 0) to month 3]
Frequency and severity of ocular and non-ocular adverse events over time. [from baseline (month 0) to month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of Shanghai Jiaotong University	Shanghai	Shanghai	China
2	Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
3	The Eye Hospital of Wenzhou Medical University	Wenzhou	Zhejiang	China	325000