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

Sun Yat-sen University

Status: Completed

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: verteporfin; Drug: verteporfin and ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03459144

2017KYPJ093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

photodynamic therapy

Experimental group

Description:

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).

Treatment:

Drug: verteporfin and ranibizumab

Drug: verteporfin

intravitreal ranibizumab

Experimental group

Description:

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).

Treatment:

Drug: verteporfin and ranibizumab

Drug: verteporfin

combination therapy of PDT and IVR

Experimental group

Description:

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).

Treatment:

Drug: verteporfin and ranibizumab

Drug: verteporfin