Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

September 17, 2019 updated by: Lin Lu, Sun Yat-sen University

Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy: A Prospective Randomized Multicenter Study

The purpose of this study is to determine whether double-dose Ranibizumab are effective to regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy (PCV).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Recently, it's reported that intravitreal high dose Lucentis®（Ranibizumab） could benefit to both regression of the polyps and the relief of macular edema in PCV patients. Since it was a single arm prospective study with a relatively small sample size, randomized clinical trials were needed to confirm the efficacy of high dose Ranibizumab in PCV treatment. In this study, the investigator will compare the efficacy of double-dose (1mg, 3+prn) Raibizumab with regular dose (0.5mg, 3+prn) for PCV treatment.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center Guangzhou
      • Shenzhen, Guangdong, China, 518040
        • Retina surgery department, Shenzhen Eye Hospital of Second Clinical Medical College of Jinan University
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • The First People's Hospital of Xuzhou
    • Shanghai
      • Shanghai, Shanghai, China, 201100
        • Dept. of Ophthalmology，Minhang hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 50 years and ≤80;
  • Active PCV confirmed by ICGA+FFA (Indocyanine green angiography + fundus fluorescein angiography);
  • At least one distinguishable polyp was shown in ICGA;
  • BCVA between 24 to 73 letters with ETDRS chart (Early Treatment of Diabetic Retinopathty Study);
  • The greatest linear dimension of the lesion <5400μm.

Exclusion Criteria:

  • Previously received treatment of laser retina photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood or any investigational treatment;
  • Previous photodynamic therapy or anti-Vegf treatment within 6 months in study eye
  • Previously received treatment of photodynamic treatment within 1 month, or any anti-vascular endothelial growth factor (VEGF) intraocular injection in 3 months in the fellow eye;
  • Combine of current vitreous hemorrhage or extensive subretinal hemorrhage (lesion area >30mm2);
  • A history of angioid streaks, presumed ocular histoplasmosis syndrome or pathologic myopia;
  • Experienced retinal pigmental epithelium (RPE) tear, retinal detachment, macular hole or uncontrolled glaucoma;
  • Undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation);
  • Cataract extraction with intraocular lens implantation within 60 days;
  • Combine of cataract that could require medical or surgical intervention during 12 months;
  • Combine of diabetes mellitus and have poor glucose control (Haemoglobin A1c (HbA1c) >8%);
  • Combine of hypertension and have poor blood pressure control (blood pressure ≥140/95 mmHg after regular antihypertensive drugs treatment);
  • History of myocardial infarction or cerebral infarction in last 6 months;
  • During gestation period or lactation period;
  • Combine of confirmed systemic autoimmune disease or any uncontrollable clinical conditions (e.g. HIV, malignant tumor, active hepatitis, severe systemic disease, diseases need immediately surgical treatment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: double-dose

double-dose

Lucentis® (Raibizumab), 1mg, 3+prn
Drug: Lucentis® (Raibizumab) double-dose
Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 1mg of Lucentis® (Raibizumab). Intervention 'double-dose: Ranibizumab 1mg, 3 injection plus prn' has not been included in any Arm/Group Descriptions.
Active Comparator: regular-dose

regular-dose

Lucentis® (Raibizumab), 0.5mg, 3+prn
Drug: Lucentis® (Raibizumab) regular-dose
Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 0.5mg of Lucentis® (Raibizumab). regular-dose: Ranibizumab 0.5mg, 3 injection plus prn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who have at least 1 polyp resolution
Time Frame: 6 months
Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of best corrected visual acuity(BCVA)
Time Frame: Baseline to 6 months
Mean change in BCVA, from baseline to the end of 6 month. As assessed by changes of number of letters with the ETDRS (Early Treatment of Diabetic Retinopathy Study) chart
Baseline to 6 months
change of central foveal thickness
Time Frame: Baseline to 6 months
Mean change of central foveal thickness, from baseline to the end of 6 month. As assessed by optical coherence tomography scanning
Baseline to 6 months
Injection frequency
Time Frame: Baseline to 6 months
Average injection number(from baseline to the end of 6 month), assessed by the number of intravitreal injection from baseline to month 6
Baseline to 6 months
Safety analysis: number of adverse event
Time Frame: 6 months
Serious ocular adverse events in the study eye, including reduced VA, retinal hemorrhage, endophthalmitis, corneal edema, iridocyclitis, macular degeneration, retinal artery occlusion, retinal tear, retinal vein occlusion and vitreous floaters. Antiplatelet Trialists' Collaboration (APTC) arterial thromboembolic events (ATEs): including deaths (vascular or unknown cause), nonfatal myocardial infarction and hemorrhagic or ischemic nonfatal cerebrovascular accident. Serious adverse event of special interest, including ATE, bleeding/hemorrhage in central nervous system (CNS) or non-CNS, congestive heart failure, fistulae, gastrointestinal perforation, hypertension, venous thrombotic events and wound healing complications.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Lin Lu, MD, phD, Zhongshan Ophthalmic Center Guangzhou, Guangdong China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 12, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

May 1, 2016

First Submitted That Met QC Criteria

May 8, 2016

First Posted (Estimate)

May 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DREAM STUDY (Pear Therapeutics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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