International, multicenter, randomised, double-blind, sham-controlled, 2x2 cross over phase III clinical trial to assess the efficacy and security of an intravitreal injection of Etamsylate in the improvement of visual acuity of patients with dry age-related macular degeneration.
- Conditions
- Aged related macula degeneration (AMD)MedDRA version: 20.0 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-003899-31-PT
- Lead Sponsor
- DOBECURE, S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
•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
•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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method