A Phase 4 interventional study of conbercept and Initial PDT in Polypoidal Choroidal Vasculopathy, sponsored by The Eye Hospital of Wenzhou Medical University. Completed at 3 sites in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by The Eye Hospital of Wenzhou Medical University · Phase 4, Interventional, and Treatment
To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).
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.
55 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 5 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 40 interventional studies indexed under Polypoidal Choroidal Vasculopathy.
Browse Polypoidal Choroidal Vasculopathy studies →The Eye Hospital of Wenzhou Medical University is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
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
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
Total number of treatments with PDT and conbercept respectively
Time frame: 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
Polyps regression, assessed by Indocyanine Green Angiography (ICGA)
Time frame: 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
Frequency and severity of ocular and non-ocular adverse events over time.
Time frame: from baseline (month 0) to month 12
Plan to share: Undecided
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Polypoidal Choroidal Vasculopathy→
The Eye Hospital of Wenzhou Medical University