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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02634970

Acronym

CANARI

Enrollment

Registered

2015-12-18

Start date

2016-03-31

Completion date

2017-12-31

Last updated

2017-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration (Wet AMD)

Keywords

wet AMD, ranibizumab, aflibercept, neovascularization

Brief 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 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.

Interventions

DRUGRanibizumab

0.5 mg, intravitreal injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Mean change in Central Subfield Retinal Thickness (CSRT)	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).

Secondary

Measure	Time frame	Description
Mean change in Subfoveal Retinal Thickness (SRT)	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).
Mean change in Subretinal Fluid (SF)	Monthly, from baseline to Month 6	Measured through Optical Coherence Tomography (OCT).
Change in Central Subfield Retinal Volume (CSRV)	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).
Mean change in Intra-Retinal Cystoid changes (IRCs) volume	Monthly, from baseline to Month 6	Measured through Optical Coherence Tomography (OCT).
Mean change in Pigment Epithelial Detachments (PEDs)	Monthly, from baseline to Month 6	Measured through Optical Coherence Tomography (OCT).
Mean change in Central Subfield Retinal Thickness (CSRT)	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).
Rate of change in Subfoveal Retinal Thickness (SRT)	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
Rate of change in Central Subfield Retinal Thickness (CSRT)	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
Rate of change in Intra-Retinal Cystoid (IRCs)	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
Rate of change in Pigment Epithelial Detachments (PEDs)	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
Rate of Dry Retina	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
Mean change of Best-Corrected Visual Acuity (BCVA)	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026