A Phase 3 interventional study of Bevacizumab (Lumiere®) in Age-Related Macular Degeneration, sponsored by Laboratorio Elea Phoenix S.A.. Completed at 3 sites in Argentina. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Laboratorio Elea Phoenix S.A. · Phase 3, Interventional, and Treatment
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 22 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Laboratorio Elea Phoenix S.A. is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with contraindication to receive bevacizumab:
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.
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.
Time frame: 6 months
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
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Laboratorio Elea Phoenix S.A.