Clinical trial NCT03459144: Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
Official title: Comparison of the Effects of Photodynamic Therapy, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: polypoidal choroidal vasculopathy
photodynamic therapy
ranibizumab
combination therapy
cost-benefit
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin, Ph.D.
role: STUDY_CHAIR
References:
citation: Lai K, Li Y, Zhou L, Zhong X, Huang C, Xu F, Lu L, Ge J, Jin C. Comparison of the effects of photodynamic therapy, intravitreal ranibizumab and combination for polypoidal choroidal vasculopathy under 1 + PRN regimen. BMC Ophthalmol. 2018 Jun 20;18(1):144. doi: 10.1186/s12886-018-0801-7.