Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668054
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Laboratorio Elea Phoenix S.A.

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Bevacizumab (Lumiere®) Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, multicenter study for evaluating the safety and clinical effectiveness of intravitreal bevacizumab
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

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.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events codified using MedDRA. [ Time Frame: 6 months ]
    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 :
  1. Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD. [ Time Frame: 6 months ]
  2. Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD. [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668054


Locations
Layout table for location information
Argentina
Consultorios Médicos Dr. Benisek
Buenos Aires, Argentina, 1636
Instituto Scorsetti S.A.
Buenos Aires, Argentina, 1636
Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)
Buenos Aires, Argentina
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
Investigators
Layout table for investigator information
Principal Investigator: Daniel Benisek, MD Consultorios Médicos Dr. Benisek
Publications of Results:
Layout table for additonal information
Responsible Party: Laboratorio Elea Phoenix S.A.
ClinicalTrials.gov Identifier: NCT03668054    
Other Study ID Numbers: LUM2016
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors