Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degeneration (Wet AMD)
|ClinicalTrials.gov Identifier: NCT03668054|
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Macular Degeneration||Drug: Bevacizumab (Lumiere®)||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|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)|
|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|
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.
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668054
|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|
|Principal Investigator:||Daniel Benisek, MD||Consultorios Médicos Dr. Benisek|