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

NCT03459144 | Completed DMC

• 1 other identifier: 2017KYPJ093
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

polypoidal choroidal vasculopathy; photodynamic therapy; ranibizumab; combination therapy; cost-benefit

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity

  the best corrected visual acuity is the Primary Outcome Measure

  12 months

Study Arms (3)

photodynamic therapy

EXPERIMENTAL

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

intravitreal ranibizumab

EXPERIMENTAL

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

combination therapy of PDT and IVR

EXPERIMENTAL

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

Interventions

verteporfin DRUG

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

combination therapy of PDT and IVR; intravitreal ranibizumab; photodynamic therapy

verteporfin and ranibizumab DRUG

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.

combination therapy of PDT and IVR; intravitreal ranibizumab; photodynamic therapy

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active macula-involved polypoidal lesions evidenced by ICGA;
• greatest linear dimension of 5400 μm or less assessed by ICGA;
• follow-up of at least 12 months.

You may not qualify if:

• any other ocular disease, such as ocular trauma, glaucoma, uveitis, diabetic retinopathy, angioid streaks, pathologic myopia, or presumed ocular histoplasmosis syndrome;
• any systemic contraindication to the PDT, IVR, sodium fluorescein, or indocyanine green dyes;
• any severe uncontrolled systemic disease, such as uncontrolled hypertention, coronary heart disease, liver failure, or kidney failure.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 29925341 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Verteporfin; Ranibizumab

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chenjin Jin, Ph.D.

  State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 8, 2018
• Study Start: December 1, 2012
• Primary Completion: July 30, 2015
• Study Completion: July 30, 2015
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

CN (1)