An interventional study of verteporfin and verteporfin and ranibizumab in Polypoidal Choroidal Vasculopathy, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
The aim of this study is to compare the outcomes of different treatment methods including photodynamic therapy (PDT), intravitreal ranibizumab injection (IVR) and combination therapy under the "1+PRN" treatment regimen for polypoidal choroidal vasculopathy (PCV) and find the optimal treatment for PCV.
The optimal treatment for PCV is still under debate. Little knowledge is known about the treatment effect of "1+pro re nata(PRN)" treatment regimen for PCV. The aim of this study is to compare the outcomes of different treatment methods including PDT, IVR and combination therapy under the "1+PRN" treatment regimen for PCV.
The study is the first prospective randomized controlled trial about different treatment methods on PCV under "1+PRN" treatment regimen. The null hypothesis of the study is that combination therapy may be the optimal treatment method for PCV. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the optimal treatment for PCV.
54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 39 interventional studies indexed under Polypoidal Choroidal Vasculopathy.
Browse Polypoidal Choroidal Vasculopathy studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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Exclusion Criteria:
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Participants will be given the standard verteporfin photodynamic therapy at baseline followed by additional standard verteporfin PDT as needed (every three months)(namely 1+PRN regimen).
Drug: verteporfin · Drug: verteporfin and ranibizumab
Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab will be given to the participants when necessary (every month) (namely 1+PRN regimen).
Drug: verteporfin · Drug: verteporfin and ranibizumab
Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the standard verteporfin PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary (every month)(namely 1+PRN regimen).
Drug: verteporfin · Drug: verteporfin and ranibizumab
Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.
Also known as: ranibizumab
Drug pages: Verteporfin · Ranibizumab
Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.
Best corrected visual acuity
the best corrected visual acuity is the Primary Outcome Measure
Time frame: 12 months
Plan to share: Undecided
Ran from Dec 2012 to primary completion in Jul 2015, 31 months.
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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verteporfin
Polypoidal Choroidal Vasculopathy →