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Wet Age-related Macular Degeneration (Wet AMD)Phase 4CANARINCT02634970

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

A Phase 4 study testing Ranibizumab in people with Wet Age-related Macular Degeneration (Wet AMD), run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2016to Dec 2017
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

About this study

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.

Being tested
Ranibizumab
Keywords
wet AMD, ranibizumab, aflibercept, neovascularization
Medical subject headings
Neovascularization, Pathologic

What participants receive

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

Study groups in NCT02634970
Study groupRoleWhat they receive
Ranibizumab at 0.5 mgExperimentalSingle arm, intravitreal injection
Receives: Drug: Ranibizumab

What is being measured

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

  1. Mean change in Central Subfield Retinal Thickness (CSRT)

    Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).

    Measured: at Day 90 (Month 3) and Day 180 (Month 6)

Secondary outcomes (12)

  1. Mean change in Central Subfield Retinal Thickness (CSRT)

    Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).

    Measured: Monthly, from baseline to Month 6

  2. Mean change in Subfoveal Retinal Thickness (SRT)

    Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).

    Measured: Monthly, from baseline to Month 6

  3. Change in Central Subfield Retinal Volume (CSRV)

    Change (in absolute and percentage terms) in subfoveal retinal thickness (SRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).

    Measured: Monthly, from baseline to Month 6

  4. Mean change in Subretinal Fluid (SF)

    Measured through Optical Coherence Tomography (OCT).

    Measured: Monthly, from baseline to Month 6

  5. Mean change in Intra-Retinal Cystoid changes (IRCs) volume

    Measured through Optical Coherence Tomography (OCT).

    Measured: Monthly, from baseline to Month 6

  6. Mean change in Pigment Epithelial Detachments (PEDs)

    Measured through Optical Coherence Tomography (OCT).

    Measured: Monthly, from baseline to Month 6

  7. Mean change of Best-Corrected Visual Acuity (BCVA)

    Best-corrected visual acuity (BCVA) will be assessed in a sitting position using subjective refraction and ETDRS-like visual acuity testing charts.

    Measured: Monthly, from baseline to Month 6

  8. Rate of change in Subfoveal Retinal Thickness (SRT)

    Rates will be assessed with the proportion of patients with changes.

    Measured: Monthly, from baseline to Month 6

  9. Rate of change in Central Subfield Retinal Thickness (CSRT)

    Rates will be assessed with the proportion of patients with changes.

    Measured: Monthly, from baseline to Month 6

  10. Rate of change in Intra-Retinal Cystoid (IRCs)

    Rates will be assessed with the proportion of patients with changes.

    Measured: Monthly, from baseline to Month 6

  11. Rate of change in Pigment Epithelial Detachments (PEDs)

    Rates will be assessed with the proportion of patients with changes.

    Measured: Monthly, from baseline to Month 6

  12. Rate of Dry Retina

    Rates will be assessed with the proportion of patients with changes.

    Measured: Monthly, from baseline to Month 6

Timeline

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

  1. First posted18 Dec 2015 (estimated)
  2. Study startMar 2016 (estimated)
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02634970
Sponsor's protocol ID
CRFB002ACA09
Acronym
CANARI
Status last verified
Feb 2017
First submitted
16 Dec 2015
Last updated
15 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ranibizumab in people with Wet Age-related Macular Degeneration (Wet AMD), run by Novartis Pharmaceuticals.

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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 withdrawn before enrolling participants, so there are no results.

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?

Mean change in Central Subfield Retinal Thickness (CSRT) (time frame: at Day 90 (Month 3) and Day 180 (Month 6)). 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 NCT02634970.

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 15 Feb 2017.

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