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

NCT02634970 | Withdrawn Phase 4

• 1 other identifier: CRFB002ACA09
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wet Age-related Macular Degeneration (Wet AMD)

Keywords

wet AMD, ranibizumab, aflibercept, neovascularization

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (12)

• Mean change in Central Subfield Retinal Thickness (CSRT)

  Monthly, from baseline to Month 6

• Mean change in Subfoveal Retinal Thickness (SRT)

  Monthly, from baseline to Month 6

• Change in Central Subfield Retinal Volume (CSRV)

  Monthly, from baseline to Month 6

• Mean change in Subretinal Fluid (SF)

  Monthly, from baseline to Month 6

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

  Monthly, from baseline to Month 6

Study Arms (1)

Ranibizumab at 0.5 mg

EXPERIMENTAL

Single arm, intravitreal injection

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0.5 mg, intravitreal injection

Ranibizumab at 0.5 mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Neovascularization, Pathologic

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02