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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668054
• Other study ID #: LUM2016
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: October 2020
• Source: Laboratorio Elea Phoenix S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Argentina	Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)	Buenos Aires
Argentina	Consultorios Médicos Dr. Benisek	Buenos Aires
Argentina	Instituto Scorsetti S.A.	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorio Elea Phoenix S.A.

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

Benisek DA, Manzitti J, Scorsetti D, Ascarza AMR, Ascarza AA, Rancaño DG, Quercia R, Gismondi MR, Total MAC, Scorsetti ML, Spitzer E, Lombas C, Deprati M, Penna MI, Fernández F, Tinelli MA. Safety and clinical effectiveness of intravitreal administration — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.		6 months
Secondary	Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.		6 months