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

Phase 4

Withdrawn

• Conditions: Wet Age-related Macular Degeneration (Wet AMD)
• Interventions: Drug: Ranibizumab

• Registration Number: NCT02634970
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-18
• Study Start: 2016-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab at 0.5 mg	Ranibizumab	Single arm, intravitreal injection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean change in Subretinal Fluid (SF)	Monthly, from baseline to Month 6	Measured through Optical Coherence Tomography (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 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.
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.
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 Dry Retina	Monthly, from baseline to Month 6	Rates will be assessed with the proportion of patients with changes.
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).
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).