Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen

Sun Yat-sen University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

verteporfinDRUG

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）.

verteporfin and ranibizumabDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Best corrected visual acuity

the best corrected visual acuity is the Primary Outcome Measure

Time frame: 12 months

Data from ClinicalTrials.gov

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