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

Sponsor
Laboratorio Elea Phoenix S.A.
Study ID
NCT03668054
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 12, 2018
Start date
Feb 7, 2017
Status verified
Oct 2020
Primary completion
May 30, 2018
Completion
May 30, 2018

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of participants with treatment-related adverse events codified using MedDRA. [ Time Frame: 6 months ]

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