Age-Related Macular Degeneration.
Conditions
Interventions
Group I (Control A): Intravitreal treatment with antibody Bevacizumab (Avastin®) (monthly scheme for one year).
Group II (Control B): Intravitreal treatment with antibody Bevacizumab (Avastin®) (month
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age between 50-70 years inclusive. 2) Patients with choroidal neovascularization (CNV) secondary to macular degeneration (ARMD) subfoveal including retinal angiomatous proliferation (RAP) or polypoidal choroidal vasculopathy (VCP). 3) foveal center directly affected by CNV, fluid or blood derivative thereof. 4) area greater than 50% of the lesion, except in cases with serous retinal pigment epithelium NVC. 5) Best corrected visual acuity (BCVA) = 25 ETDRS letters primer. 6) Voluntary patient by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1) Presence of any of the following disorders / eye procederes: a) atrophy, bleeding or scarring of more than 50% of the lesion, b) subfoveal subretinal hemorrhage over an area of the disc, c) pigment epithelium tear, d) pretreatment on the eye: laser photocoagulation, photodynamic therapy, peri- or intraocular triamcinolone, e) after injection of anti-VEGF antibodies in either eye, f) cataract surgery in the past 3 months, g) media opacity, h) waterfall (which prevents adequate visualization of the fund), uveitis or glaucoma uncontrolled i) pars plana vitrectomy (PPV). 2) Patients who have received any anti-angiogenic treatment, by any means, in the last 3 months (intravitreal treatment of AMD as Lucentis [ranibizumab] Eylea® [Aflibercept; Regeneron] and / or Bevacizumab [Avastin ®], or systemic treatment of cancer). 3) Major surgery in the last 28 days. 4) history of stroke, acute myocardial infarction or other significant vascular impairment (Example: DVT) in the last 6 months. 5) Chronic diseases unbalanced (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 6) referenced immunosuppressive disease, immunosuppressive current intake / immunomodulatory drugs. 7) history of autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and severe allergic history (urticaria, dermatitis, bronchitis and persistent asthma). 8) History of allergy to any ingredient of the vaccine study, iodine, or any dye used in diagnostic techniques. 9) moderate or severe systemic infections that interfere with patient evaluation. 10) Mental incapacity to issue clear consent and act accordingly to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Adverse Events (Occurrence of EA (Yes, No). EA Description (name of event). EA intensity (mild, moderate, severe)). Measuring time: a) groups I and II: at baseline and monthly for 12 months; b) groups III and IV: at baseline, one week after each of the first 8 immunizations and thereafter at a rate monthly throughout the study. Laboratory (numerical values of hematological and biochemical tests). Measuring time: at baseline and at months 3, 6, 9 and 12. Intravitreal Injection of Bevacizumab, in addition to the three basic administered, necessary to maintain or improve the anatomical and functional parameters chosen (number of shots). Measuring time: a year of starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Signs of activity (presence of hemorrhage, cystoid macular edema, subretinal fluid and exudation). Measuring time: monthly, every ophthalmologic evaluation. Type of injury (fluorescein / indocyanine green angiography: predominantly classic, minimally classic, occult, and retinal angiomatous proliferation polypoid choroidal vasculopathy). Measuring time: 85 days and one year after starting treatment. Activity injury (fluorescein / indocyanine green angiography: active lesions, no active lesion). Measuring time: 85 days and one year after starting treatment. Location fluid (intra-retinal edema, subretinal fluid, serous epithelial detachment). Measuring time: monthly, every ophthalmologic evaluation. Number of lines (lets you know the answer in visual acuity, considering 3 categories: a) Improved if gained 3 or more lines; b) Stable, whether you win or lose less than 3 lines; c) Worsened, if you miss 3 or more lines). Measuring time: monthly, every ophthalmologic evaluation. Central macular thickness (in microns as macular map, optical coherence tomography). Measuring time: monthly, every ophthalmologic evaluation. Central macular thickness (single cut, optical coherence tomography). Measuring time: monthly, every ophthalmologic evaluation. Immune response (presence or absence of immune response to the vaccine, as measured by specific IgG titers in serum VEGF vaccinated patients of antibodies against time before vaccination, and negative and positive controls reference). Measuring time (only for groups III and IV): 29, 78 and 85, and months 4, 5, 6, 7, 8, 9, 10, 11 and 12 after the start of vaccination. | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernandez-Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed