Polypoidal Choroidal Vasculopathy
Conditions
Keywords
polypoidal choroidal vasculopathy, photodynamic therapy, ranibizumab, combination therapy, cost-benefit
Brief summary
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.
Detailed description
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.
Interventions
DRUGverteporfin
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）.
DRUGverteporfin and 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. active macula-involved polypoidal lesions evidenced by ICGA; 2. greatest linear dimension of 5400 μm or less assessed by ICGA; 3. follow-up of at least 12 months.
Exclusion criteria
1. any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome; 2. any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes; 3. any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 12 months | the best corrected visual acuity is the Primary Outcome Measure |
Countries
China
Outcome results
None listed