Age-Related Macular DegenerationPhase 3NCT03668054
Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration (Wet AMD)
A Phase 3 study testing Bevacizumab (Lumiere®) in people with Age-Related Macular Degeneration, run by Laboratorio Elea Phoenix S.A. at 3 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Bevacizumab (Lumiere®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesArgentina
- Study dates
- 7 Feb 2017to 30 May 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Consultorios Médicos Dr. Benisek
Buenos Aires, 1636
Instituto Scorsetti S.A.
Buenos Aires, 1636
Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)
Buenos Aires
About this study
Official title: Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.
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.
Read the 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
- Being tested
- Bevacizumab (Lumiere®)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab (Lumiere®) | Experimental | Dosage form: intravitreal single dose vial. Dosage: 0.05ml (1.25 mg) Frequency: monthly injections (up to 6 doses) Receives: Drug: Bevacizumab (Lumiere®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.
Measured: 6 months
Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start7 Feb 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, multicenter study for evaluating the safety and clinical effectiveness of intravitreal bevacizumab
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Benisek, MD, Principal investigator, Consultorios Médicos Dr. Benisek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668054
- Sponsor's protocol ID
- LUM2016
- Status last verified
- Oct 2020
- First submitted
- 4 Sep 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33093900
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Evaluating the Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT03668054
- Acronym / sponsor ID
- LUM2016
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, multicenter study for evaluating the safety and clinical effectiveness of intravitreal bevacizumab
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab (Lumiere®) | Experimental | Drug: Bevacizumab (Lumiere®)Dosage form: intravitreal single dose vial. Dosage: 0.05ml (1.25 mg) Frequency: monthly injections (up to 6 doses) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- Patients with contraindication to receive bevacizumab:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Bevacizumab (Lumiere®) |
Primary outcome
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.
2 secondary outcomes
Number of participants with changes in visual acuity using the ETDRS charts in patients with wet AMD.
Time frame: 6 months
Number of participants with changes in retinal thickness as assessed by OCT in patients with wet AMD.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Results publication: PubMed 33093900Benisek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Benisek, MD principal investigator
Consultorios Médicos Dr. Benisek
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab (Lumiere®) in people with Age-Related Macular Degeneration, run by Laboratorio Elea Phoenix S.A. at 3 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events codified using MedDRA. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.