Last updated: October 26, 2020
Sponsor: Laboratorio Elea Phoenix S.A.
Overall Status: Completed
Phase
3
Condition
Aging
Myopic Macular Degeneration
Macular Degeneration
Treatment
N/AClinical Study ID
NCT03668054
LUM2016
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients over 50 years of age diagnosed with wet age-related macular degenerationhaving indication of antiangiogenic therapy.
- Both genders.
- Subjects able to give informed consent.
Exclusion
Exclusion Criteria:
- 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 recombinantantibodies or humanized antibodies.
- Patients having received intravitreal antiangiogenic therapy prior to wet AMDtreatment.
- 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 threemonths.
- Vitrectomy in the affected eye.
- Any significant ocular infection, active or suspected, having compromised or able tocompromise 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.
Study Design
Total Participants: 22
Study Start date:
February 07, 2017
Estimated Completion Date:
May 30, 2018
Study Description
Connect with a study center
Consultorios Médicos / Clínica de Cirugía Especializada S.A. (CCE)
Buenos Aires,
ArgentinaSite Not Available
Consultorios Médicos Dr. Benisek
Buenos Aires, 1636
ArgentinaSite Not Available
Instituto Scorsetti S.A.
Buenos Aires, 1636
ArgentinaSite Not Available
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