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Polypoidal Choroidal VasculopathyPhase 2/3NCT02769169

Double-dose Ranibizumab for Polypoidal Choroidal Vasculopathy

A Phase 2/3 study testing Lucentis® (Raibizumab) double-dose and Lucentis® (Raibizumab) regular-dose in people with Polypoidal Choroidal Vasculopathy, run by Sun Yat-sen University at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Polypoidal Choroidal Vasculopathy
What is being tested?
Lucentis® (Raibizumab) double-dose and Lucentis® (Raibizumab) regular-dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
4 sitesChina
Study dates
1 Aug 2018to 15 Dec 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Zhongshan Ophthalmic Center Guangzhou

    Guangzhou, Guangdong, 510060

  • Dept. of Ophthalmology，Minhang hospital, Fudan University

    Shanghai, Shanghai Municipality, 201100

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

    Shenzhen, Guangdong, 518040

  • The First People's Hospital of Xuzhou

    Xuzhou, Jiangsu, 221002

Other trials in China

About this study

Official title: 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).

Read the 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.

Being tested
Lucentis® (Raibizumab) double-dose, Lucentis® (Raibizumab) regular-dose
Keywords
Ranibizumab, regression of the polyps
Medical subject headings
Polypoidal Choroidal Vasculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lucentis® (Raibizumab) double-doseDrug

    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.

  • Lucentis® (Raibizumab) regular-doseDrug

    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

Study groups in NCT02769169
Study groupRoleWhat they receive
double-doseExperimentaldouble-dose Lucentis® (Raibizumab), 1mg, 3+prn
Receives: Drug: Lucentis® (Raibizumab) double-dose
regular-doseActive comparatorregular-dose Lucentis® (Raibizumab), 0.5mg, 3+prn
Receives: Drug: Lucentis® (Raibizumab) regular-dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (4)

  1. 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

    Measured: Baseline to 6 months

  2. 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

    Measured: Baseline to 6 months

  3. 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

    Measured: Baseline to 6 months

  4. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study start1 Aug 2018
  3. Primary completion12 Sep 2018
  4. Study completion15 Dec 2018

Why it stopped: study protocol changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02769169
Sponsor's protocol ID
DREAM STUDY
Status last verified
Sep 2019
First submitted
1 May 2016
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23352196

  • 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.

    PubMed 22426346

  • 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.

    PubMed 25646029

  • 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.

    PubMed 19726427

  • 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.

    PubMed 16897221

  • 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.

    PubMed 14557174

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Lucentis® (Raibizumab) double-dose and Lucentis® (Raibizumab) regular-dose in people with Polypoidal Choroidal Vasculopathy, run by Sun Yat-sen University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: study protocol changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who have at least 1 polyp resolution (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02769169, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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