Extension study for the follow up of patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulated and blinded controlled treatment to evaluate safety and efficacy of a drug administered (etamsilato) via a needle in the eye. Clinical trial code OFT-ETAMSILATO -4.2.1
- Conditions
- Aged related macula degeneration (ARMD)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-001812-36-ES
- Lead Sponsor
- Dr. Pedro Cuevas Sanchez (Investigacion Independiente)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 44
-Patients who show response to treatment (lose 15 or more letters in the ETDRS chart) in the treated eyeat week 16 after administration of the double-blinded treatment.
-Able and in agreement to follow the study protocol and to give the inform consent.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
-Patients with concomitant illness that, based on the investigator judgment, could interfere (due to the disease itself or due to the associate treatment) in the development, evolution or evaluation of the ARMD, as diabetes mellitus with ocular affectation, active or ongoing systemic infection, any other ocular infection, psychiatric alterations, social situation, which could interfere in the compliance with the study requirements and so on.
-Pregnant or breast-feeding
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