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

NCT ID: NCT03668054

Last Updated: 2020-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2018-05-30

Brief 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.

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab (Lumiere®)

Dosage form: intravitreal single dose vial. Dosage: 0.05ml (1.25 mg) Frequency: monthly injections (up to 6 doses)

Group Type: EXPERIMENTAL

Bevacizumab (Lumiere®)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorio Elea Phoenix S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Benisek, MD

Role: PRINCIPAL_INVESTIGATOR

Consultorios Médicos Dr. Benisek

Locations

Consultorios Médicos Dr. Benisek

Buenos Aires, , Argentina

Instituto Scorsetti S.A.

Buenos Aires, , Argentina

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

Buenos Aires, , Argentina

Countries

Argentina

References

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.

Reference Type: RESULT

PMID: 33093900 (View on PubMed)

Other Identifiers

LUM2016

Identifier Type: -

Identifier Source: org_study_id