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

Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Bevacizumab (Lumiere®)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1636
    • Consultorios Médicos Dr. Benisek
  • Buenos Aires, Argentina, 1636
    • Instituto Scorsetti S.A.
  • Buenos Aires, Argentina
    • Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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 recombinant antibodies or humanized antibodies.
• Patients having received intravitreal antiangiogenic therapy prior to wet AMD treatment.
• 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 three months.
• Vitrectomy in the affected eye.
• Any significant ocular infection, active or suspected, having compromised or able to compromise 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab (Lumiere®); Dosage form: intravitreal single dose vial. Dosage: 0.05ml (1.25 mg) Frequency: monthly injections (up to 6 doses)	Drug: Bevacizumab (Lumiere®); The first three doses of bevacizumab (Lumiere®) were administered via intravitreal injection on a monthly basis. A safety evaluation was conducted in the first month. Following the first three doses, continuation of the treatment (up to 6 doses) was decided according to response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events codified using MedDRA.	Register reports of drug related adverse events and compare them with prevalence in the literature after intravitreal bevacizumab (Lumiere®) in the single-dose form, for the treatment of patients with neovascular AMD.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.	6 months
Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.	6 months

Collaborators and Investigators

• Sponsor: Laboratorio Elea Phoenix S.A.
• Investigators: Principal Investigator: Daniel Benisek, MD, Consultorios Médicos Dr. Benisek

Publications and helpful links

General Publications

• Benisek DA, Manzitti J, Scorsetti D, Rousselot Ascarza AM, Ascarza AA, Gomez Rancano D, Quercia R, Ramirez Gismondi M, Carpio Total MA, Scorsetti ML, Spitzer E, Lombas C, Deprati M, Penna MI, Fernandez F, Tinelli MA. Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere(R)) in patients with neovascular age-related macular degeneration. Exp Ther Med. 2020 Dec;20(6):162. doi: 10.3892/etm.2020.9291. Epub 2020 Oct 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: LUM2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No