Aged related macula degeneration (AMD) MedDRA version: 20.0 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Dicynone 250mg/2ml, injectable solution
Product Name: DICYNONE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etamsylate
Sponsors
DOBECURE, S.L
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adult patients, aged =18 years, males or females. •Diagnosis of dry AMD •Patients with best corrected visual acuity (BCVA) between 20/25 and 20/320, measured by ETDRS optotype (Early Treatment Diabetic Retinopathy Study) •Women of childbearing potential (defined as a premenopausal female capable of becoming pregnant) should be willing to follow and use the following highly effective contraconceptive methods: -Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal) -progestogen-only hormonal contraception associated with inhibition of -Ovulation (oral, injectable or implantable) -intrauterine device (IUD) -intrauterine hormone-releasing system (IUS) -bilateral tubal occlusion -vasectomised partner -sexual abstinence -postmenopausal women (defined as women that have had their last menstruation at least 12 months before study inclusion). •Patients with the capacity and disposition to follow the study protocol and procedures and that grant their informed consent in writing (signed and dated), accepting voluntarily to participate in the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: •Patients with grade 5 AMD in one or both eyes. •Patients with any concomitant ocular disease that, under investigator’s judgement, could influence the development, evaluation or assessment of the AMD, such as glaucoma, permanent structural damage in the centre of the fovea, Geographic parafoveolar atrophy, Polypoid choroidal vasculopathy etc. •Patients with ocular or periocular infection. •Patients with any concomitant disease that, under investigator’s judgement, could influence (the disease itself or its treatment) the development, evaluation or assessment of the AMD, such as diabetes mellitus with ocular affectation, current or active systemic infection, any ocular infection, psychiatric diseases, social situation that may affect study protocol compliance etc. •Patients treated with any intravitreal anti-VEGF agent or other intravitreal drug such as corticosteroids within the last month prior to study randomisation entry •Pregnant or breastfeeding women (urine pregnancy test to be performed for those patients of childbearing potential patients) •Hyper sensibility to etamsylate or any of the excipients contained in the form used for the trial. •Patients with any of the contraindicated diseases described in the SMPC of Dycinone, such us but not limited to: porphyria, bleeding caused by treatment with anticoagulants, fibrosis/benign tumours in the uterus and patients with a recent history of stroke. •Patients that have participated in Dry-AMD clinical trials with intervention (observational, epidemiologic or economic studies are allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a phase III study to assess the efficacy and safety of intravitreal injection of Etamsylate for the treatment of age-related macular degeneration. Its design will allow the evaluation (at 90 and 180 days) of the effects of an intravitreal injection of etamsylate, in order to establish the suitability of this treatment for AMD. ; Secondary Objective: •To assess the efficacy after 90 days of a single intravitreal injection of etamsylate in the improvement of visual acuity in patients diagnosed with dry AMD. •To assess the efficacy after 180 days of a single intravitreal injection of etamsylate in the improvement of visual acuity in patients diagnosed with dry AMD. ;Primary end point(s): The trial’s primary endpoint is, for each subject, the difference in number of letters read in the ETDRS optotype between the baseline values and after 90 and 180 days of a single intravitreal injection of Etamsylate expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR).;Timepoint(s) of evaluation of this end point: After 90 and 180 days from the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Evolution from baseline at 90 and 180 days after etamsylate intravitreal injection of corrected visual acuity assessed by ETDRS optotype and expressed in in negative decimal logarithmic units of the Minimum Angle Resolution (logMAR) equivalent to the number of letters accurately read. •Percentage of patients showing an improvement of the best-corrected visual acuity assessed with ETDRS. •Evolution of the thickness of the central part of the macula measured by OCT. •Evolution of the number of targeted areas of retinal pigment epithelium disappearance measured by OCT. •Evolution of the number, location, area and volume of drusen measured by OCT and colour retinography. •In those patients with the most advanced form of AMD (presence of geographical atrophy), the percentage of increase or decrease of the geographical atrophy area. •Evolution of patient’s quality of life measured by Visual Function Questionnaire of National Eye Institute (VFQ-25) and EuroQol five dimensions-five levels questionnaire (EQ-5D-5L). •Evolution compared with non-concurrent control group of corrected visual acuity assessed by ETDRS optotype. This group will include patients treated with any treatment alternatives, standard of care and observation. ;Timepoint(s) of evaluation of this end point: After 90 and 180 days from the baseline | — |
Countries
Portugal, Spain
Contacts
Public ContactCarla Nascimento
Leon Research S.L.
Outcome results
None listed