Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration (Wet AMD)

Last updated: October 26, 2020
Sponsor: Laboratorio Elea Phoenix S.A.
Overall Status: Completed

Phase

3

Condition

Aging

Myopic Macular Degeneration

Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT03668054
LUM2016
  • Ages > 50
  • All Genders

Study Summary

The purpose of this clinical trial is to evaluate the safety and clinical effectiveness of intravitreal bevacizumab (Lumiere®) in the single-dose form, for the treatment of patients with wet AMD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 50 years of age diagnosed with wet age-related macular degenerationhaving indication of antiangiogenic therapy.
  • Both genders.
  • Subjects able to give informed consent.

Exclusion

Exclusion Criteria:

  • Patients with contraindication to receive bevacizumab:
  • Hypersensitivity to the active ingredient or to some of the formula excipients.
  • Hypersensitivity to products derived from CHO cells or to other human recombinantantibodies or humanized antibodies.
  • Patients having received intravitreal antiangiogenic therapy prior to wet AMDtreatment.
  • Patients receiving previous systemic antiangiogenic therapy.
  • Wet AMD in the healing period or disciform scar.
  • Pregnant, breastfeeding or childbearing-aged women.
  • Any person with choroidal neovascularization not associated to wet AMD.
  • History of retinal or intraocular surgery in the affected eye in the last threemonths.
  • Vitrectomy in the affected eye.
  • Any significant ocular infection, active or suspected, having compromised or able tocompromise the eye to be studied.
  • Ocular inflammatory disease.
  • Myopia exceeding -8 diopters.
  • Extensive subfoveal subretinal hemorrhage > 2 papillary diameter (PD).
  • Coexistence of other severe ocular diseases: uncontrolled ocular hypertension,terminal glaucoma, diabetic retinopathy, retinal vein thrombosis, optic atrophy.
  • History of stroke or myocardial infarction in the last 6 months.
  • Patients with coagulopathies.
  • Patients physically or mentally disabled to participate in such visual tests.

Study Design

Total Participants: 22
Study Start date:
February 07, 2017
Estimated Completion Date:
May 30, 2018

Study Description

Age-related macular degeneration is the main cause of severe vision loss in patients over 65 years of age. There is solid evidence of the efficacy and safety of bevacizumab in the treatment of wet AMD. However, it has not been registered for such indication yet.

In response to the need for a proper adaptation, Lumiere® has been developed in a single-dose, sterile dosage containing bevacizumab 5 mg/vial in 0.2 mL injectable solution.

This adaptation is intended to assure intravitreal administration avoiding the risk of contamination and potential adverse consequences, such as endophthalmitis and blindness, associated to reutilization or repackaging of bevacizumab vials for oncological use.

Connect with a study center

  • Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)

    Buenos Aires,
    Argentina

    Site Not Available

  • Consultorios Médicos Dr. Benisek

    Buenos Aires, 1636
    Argentina

    Site Not Available

  • Instituto Scorsetti S.A.

    Buenos Aires, 1636
    Argentina

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.