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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Bevacizumab (Lumiere®)
Sponsored by
Laboratorio Elea Phoenix S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Consultorios Médicos Dr. Benisek
  • Instituto Scorsetti S.A.
  • Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab (Lumiere®)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.
Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.

Full Information

First Posted
September 4, 2018
Last Updated
October 26, 2020
Sponsor
Laboratorio Elea Phoenix S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03668054
Brief Title
Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration (Wet AMD)
Official Title
Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorio Elea Phoenix S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open label, multicenter study for evaluating the safety and clinical effectiveness of intravitreal bevacizumab
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab (Lumiere®)
Arm Type
Experimental
Arm Description
Dosage form: intravitreal single dose vial. Dosage: 0.05ml (1.25 mg) Frequency: monthly injections (up to 6 doses)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Lumiere®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events codified using MedDRA.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.
Time Frame
6 months
Title
Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Benisek, MD
Organizational Affiliation
Consultorios Médicos Dr. Benisek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consultorios Médicos Dr. Benisek
City
Buenos Aires
ZIP/Postal Code
1636
Country
Argentina
Facility Name
Instituto Scorsetti S.A.
City
Buenos Aires
ZIP/Postal Code
1636
Country
Argentina
Facility Name
Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Citations:
PubMed Identifier
33093900
Citation
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.
Results Reference
result

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

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