CANadian Study in Patients With Wet AMD, Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to RanIbizumab (CANARI)

February 14, 2017 updated by: Novartis Pharmaceuticals
There are limited prospective data regarding the potential benefit and risks associated with switching between anti-VEGF therapies in patients with nAMD who have initially achieved a favorable response to the first anti-VEGF therapy used but subsequently have evidence of increasing disease activity despite continuation of therapy. This study will fill this knowledge gap by prospectively evaluating the effectiveness and safety of switching from aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial treatment with aflibercept.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BCVA ≥23 ETDRS letters in study eye at both the Screening and Baseline visits.
  • Evidence, at Screening, of active, angiographically confirmed Choroidal Neovascularization (CNV) secondary to AMD, directly or indirectly affecting the center of the fovea in study eye.
  • No prior anti-VEGF treatment other than aflibercept.

Exclusion Criteria:

  • History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
  • Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.

Exclusion criteria for ocular medical history and conditions for either eye:

  • Any active periocular or ocular infection, or active intraocular inflammation at the time of Screening or Baseline (as per contraindications in the Lucentis® Product Monograph).
  • Uncontrolled glaucoma (intraocular pressure [IOP] ≥30 mm Hg on medication or according to Investigator's judgment) at the time of Screening or Baseline
  • Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral anti-VEGF injections.
  • Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye.

Study eye exclusion criteria:

  • At Baseline, intraocular surgery was performed within the previous 28 days or intraocular surgery is planned at any time during the 6 month study period
  • Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g. ocular histoplasmosis, pathologic myopia (≥-8 dioptres)) at the time of Screening and Baseline.
  • Irreversible structural damage involving the center of the fovea (e.g. advanced fibrosis or geographic atrophy) which in the opinion of the Investigator is sufficient to irreversibly impair visual acuity.
  • Polypoidal choroidal vasculopathy (PCV), RPE tear, central serous retinopathy (CSR), or significant vitreomacular traction identified during Screening period or within 4 months of Baseline visit. Note that small vitreomacular adhesions that do not result in deformity of the retina are permitted.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ranibizumab at 0.5 mg
Single arm, intravitreal injection
Drug: Ranibizumab
0.5 mg, intravitreal injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in Central Subfield Retinal Thickness (CSRT)
Time Frame: at Day 90 (Month 3) and Day 180 (Month 6)
Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).
at Day 90 (Month 3) and Day 180 (Month 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in Central Subfield Retinal Thickness (CSRT)
Time Frame: Monthly, from baseline to Month 6
Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).
Monthly, from baseline to Month 6
Mean change in Subfoveal Retinal Thickness (SRT)
Time Frame: Monthly, from baseline to Month 6
Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).
Monthly, from baseline to Month 6
Change in Central Subfield Retinal Volume (CSRV)
Time Frame: Monthly, from baseline to Month 6
Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).
Monthly, from baseline to Month 6
Mean change in Subretinal Fluid (SF)
Time Frame: Monthly, from baseline to Month 6
Measured through Optical Coherence Tomography (OCT).
Monthly, from baseline to Month 6
Mean change in Intra-Retinal Cystoid changes (IRCs) volume
Time Frame: Monthly, from baseline to Month 6
Measured through Optical Coherence Tomography (OCT).
Monthly, from baseline to Month 6
Mean change in Pigment Epithelial Detachments (PEDs)
Time Frame: Monthly, from baseline to Month 6
Measured through Optical Coherence Tomography (OCT).
Monthly, from baseline to Month 6
Mean change of Best-Corrected Visual Acuity (BCVA)
Time Frame: Monthly, from baseline to Month 6
Best-corrected visual acuity (BCVA) will be assessed in a sitting position using subjective refraction and ETDRS-like visual acuity testing charts.
Monthly, from baseline to Month 6
Rate of change in Subfoveal Retinal Thickness (SRT)
Time Frame: Monthly, from baseline to Month 6
Rates will be assessed with the proportion of patients with changes.
Monthly, from baseline to Month 6
Rate of change in Central Subfield Retinal Thickness (CSRT)
Time Frame: Monthly, from baseline to Month 6
Rates will be assessed with the proportion of patients with changes.
Monthly, from baseline to Month 6
Rate of change in Intra-Retinal Cystoid (IRCs)
Time Frame: Monthly, from baseline to Month 6
Rates will be assessed with the proportion of patients with changes.
Monthly, from baseline to Month 6
Rate of change in Pigment Epithelial Detachments (PEDs)
Time Frame: Monthly, from baseline to Month 6
Rates will be assessed with the proportion of patients with changes.
Monthly, from baseline to Month 6
Rate of Dry Retina
Time Frame: Monthly, from baseline to Month 6
Rates will be assessed with the proportion of patients with changes.
Monthly, from baseline to Month 6

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRFB002ACA09

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings