CIGB-247-V vaccine in Age-Related Macular Degeneration, phase I-II randomized.

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000189
• Date of registration: 10/11/2014
• Prospective Registration: Yes
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: CIGB-247-V vaccine in Age-Related Macular Degeneration, phase I-II randomized.
• Scientific title: Use of the CIGB-247-V vaccine candidate in the treatment of Age-Related Macular Degeneration.
• Date of first enrolment: 01/03/2015
• Target sample size: 66
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000189-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 1-2

Countries of recruitment

Cuba

Contacts

• Name: Francisco Hernandez-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Francisco Hernandez-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion 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: 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.

Age minimum: 50 years
Age maximum: 70 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Age-Related Macular Degeneration.

Intervention(s)

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®) (monthly schedule for 3 months and then as ophthalmologic clinical requirement).
Group III (Study): hVEGFKDR- p64K antigen (400 ug) + adjuvant NAcGM3 / VSSPs (200 ug) applied subcutaneously in the deltoid region + intravitreal treatment with antibody Bevacizumab (Avastin®) (monthly schedule for 3 months and then as required ophthalmological) clinician.
Group IV (Study): antigen p64K-hVEGFKDR- (800 ug) + adjuvant NAcGM3 / VSSPs (200 ug) applied subcutaneously in the deltoid region + Intravitreal treatment with antibody Bevacizumab (Avastin®) (monthly schedule for 3 months and then as required ophthalmological) clinician.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

IG/CIGB-247I/DM/1301

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, CUBA.

Secondary Sponsor(s)

Not applicable