NCT03668054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

September 4, 2018

Last Update Submit

October 26, 2020

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Bevacizumab (Lumiere®)

EXPERIMENTAL

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

Drug: Bevacizumab (Lumiere®)

Interventions

Bevacizumab (Lumiere®)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.

Bevacizumab (Lumiere®)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Consultorios Médicos Dr. Benisek

Buenos Aires, 1636, Argentina

Location

Instituto Scorsetti S.A.

Buenos Aires, 1636, Argentina

Location

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

Buenos Aires, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 33093900RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Daniel Benisek, MD

    Consultorios Médicos Dr. Benisek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label, multicenter study for evaluating the safety and clinical effectiveness of intravitreal bevacizumab
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 12, 2018

Study Start

February 7, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

AR(3)