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Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Lucentis® (Raibizumab) double-dose

Lucentis® (Raibizumab) regular-dose

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring Ranibizumab, regression of the polyps

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Zhongshan Ophthalmic Center Guangzhou
Retina surgery department, Shenzhen Eye Hospital of Second Clinical Medical College of Jinan University
The First People's Hospital of Xuzhou
Dept. of Ophthalmology，Minhang hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

double-dose

regular-dose

Arm Description

double-dose Lucentis® (Raibizumab), 1mg, 3+prn

regular-dose Lucentis® (Raibizumab), 0.5mg, 3+prn

Outcomes

Primary Outcome Measures

Number of participants who have at least 1 polyp resolution

Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6

Secondary Outcome Measures

change of best corrected visual acuity(BCVA)

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

change of central foveal thickness

Mean change of central foveal thickness, from baseline to the end of 6 month. As assessed by optical coherence tomography scanning

Injection frequency

Average injection number(from baseline to the end of 6 month), assessed by the number of intravitreal injection from baseline to month 6

Safety analysis: number of adverse event

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.

Full Information

NCT ID

NCT02769169

First Posted

May 1, 2016

Last Updated

September 17, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02769169

Brief Title

Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

study protocol changed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

September 12, 2018 (Actual)

Study Completion Date

December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polypoidal Choroidal Vasculopathy

Keywords

Ranibizumab, regression of the polyps

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

double-dose

Arm Type

Experimental

Arm Description

double-dose Lucentis® (Raibizumab), 1mg, 3+prn

Arm Title

regular-dose

Arm Type

Active Comparator

Arm Description

regular-dose Lucentis® (Raibizumab), 0.5mg, 3+prn

Intervention Type

Drug

Intervention Name(s)

Lucentis® (Raibizumab) double-dose

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lucentis® (Raibizumab) regular-dose

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants who have at least 1 polyp resolution

Description

Number of participants who have at least 1 polyp resolution, assessed by Indocyanine angiography (ICGA) between baseline and Month 6

Time Frame

6 months

Secondary Outcome Measure Information:

Title

change of best corrected visual acuity(BCVA)

Description

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

Time Frame

Baseline to 6 months

Title

change of central foveal thickness

Description

Mean change of central foveal thickness, from baseline to the end of 6 month. As assessed by optical coherence tomography scanning

Time Frame

Baseline to 6 months

Title

Injection frequency

Description

Average injection number(from baseline to the end of 6 month), assessed by the number of intravitreal injection from baseline to month 6

Time Frame

Baseline to 6 months

Title

Safety analysis: number of adverse event

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lin Lu, MD, phD

Organizational Affiliation

Zhongshan Ophthalmic Center Guangzhou, Guangdong China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Ophthalmic Center Guangzhou

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Name

Retina surgery department, Shenzhen Eye Hospital of Second Clinical Medical College of Jinan University

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518040

Country

China

Facility Name

The First People's Hospital of Xuzhou

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221002

Country

China

Facility Name

Dept. of Ophthalmology，Minhang hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201100

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23352196

Citation

Busbee BG, Ho AC, Brown DM, Heier JS, Suner IJ, Li Z, Rubio RG, Lai P; HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013 May;120(5):1046-56. doi: 10.1016/j.ophtha.2012.10.014. Epub 2013 Jan 23.

Results Reference

result

PubMed Identifier

22426346

Citation

Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.

Results Reference

result

PubMed Identifier

25646029

Citation

Kokame GT. Prospective evaluation of subretinal vessel location in polypoidal choroidal vasculopathy (PCV) and response of hemorrhagic and exudative PCV to high-dose antiangiogenic therapy (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2014 Jul;112:74-93.

Results Reference

result

PubMed Identifier

19726427

Citation

Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1.

Results Reference

result

PubMed Identifier

16897221

Citation

Obata R, Yanagi Y, Kami J, Takahashi H, Inoue Y, Tamaki Y. Polypoidal choroidal vasculopathy and retinochoroidal anastomosis in Japanese patients eligible for photodynamic therapy for exudative age-related macular degeneration. Jpn J Ophthalmol. 2006 Jul-Aug;50(4):354-360. doi: 10.1007/s10384-005-0337-2.

Results Reference

result

PubMed Identifier

14557174

Citation

Sho K, Takahashi K, Yamada H, Wada M, Nagai Y, Otsuji T, Nishikawa M, Mitsuma Y, Yamazaki Y, Matsumura M, Uyama M. Polypoidal choroidal vasculopathy: incidence, demographic features, and clinical characteristics. Arch Ophthalmol. 2003 Oct;121(10):1392-6. doi: 10.1001/archopht.121.10.1392.

Results Reference

result

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Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

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