Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

NCT02769169 | Terminated Phase 2 DMC

• 1 other identifier: DREAM STUDY
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

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).

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Ranibizumab, regression of the polyps

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

• change of best corrected visual acuity(BCVA)

  Baseline to 6 months

• change of central foveal thickness

  Baseline to 6 months

• Injection frequency

  Baseline to 6 months

• Safety analysis: number of adverse event

  6 months

Study Arms (2)

double-dose

EXPERIMENTAL

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

Drug: Lucentis® (Raibizumab) double-dose

regular-dose

ACTIVE COMPARATOR

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

Drug: Lucentis® (Raibizumab) regular-dose

Interventions

Lucentis® (Raibizumab) double-dose DRUG

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.

double-dose

Lucentis® (Raibizumab) regular-dose DRUG

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

regular-dose

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (4)

Zhongshan Ophthalmic Center Guangzhou

Guangzhou, Guangdong, 510060, China

Location

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

Shenzhen, Guangdong, 518040, China

Location

The First People's Hospital of Xuzhou

Xuzhou, Jiangsu, 221002, China

Location

Dept. of Ophthalmology，Minhang hospital, Fudan University

Shanghai, Shanghai Municipality, 201100, China

Location

Related Publications (6)

• 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.

  PMID: 23352196 RESULT

• 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.

  PMID: 22426346 RESULT

• 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.

  PMID: 25646029 RESULT

• 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.

  PMID: 19726427 RESULT

• 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.

  PMID: 16897221 RESULT

• 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.

  PMID: 14557174 RESULT

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lin Lu, MD, phD

  Zhongshan Ophthalmic Center Guangzhou, Guangdong China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD，Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 11, 2016
• Study Start: August 1, 2018
• Primary Completion: September 12, 2018
• Study Completion: December 15, 2018
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (4)