Open extension study for 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

Phase 1

• Conditions: Aged related macula degeneration (ARMD); Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-005556-25-ES
• Lead Sponsor: Investigacion Independiente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-17
• Study Completion: 2017-09-15
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

-Patients diagnosed of dry or wet ARMD, who completed the clinical trial with protocol code OFT-ethamsylate-4.2.1
-Able and in agreement to follow the study protocol and to give the inform consent.
Inclusion criteria to provide treatment with intravitreal ethamsylate in the same treated eye in the clinical trial:
-Patients who show no response to treatment (lose 15 or more letters in the ETDRS chart) in the treated eye in the trial between weeks 4 and 16 after administration of the double-blinded treatment.
-Based on investigator judgment is the most appropriate treatment option.
Inclusion criteria to provide treatment with intravitreal ethamsylate in the contralateral eye:
- Patients who show treatment response (lost 14 or fewer letters in the ETDRS chart) in the treated eye in the clinical trial at 16 weeks
-The contralateral eye (untreated in the clinical trial) has a dry or wet ARMD, diagnosed later than the previous two years
-Grade 5 ARMD.
-The best visual acuity correted between 20/25 and 20/320, evaluated with optotype ETDRS
-Not present any ocular pathology, based on investigator judgment could interfere in the development, evolution and evaluation of ARMD as glaucoma, permanent structural damage in central foveal, parafoveolar geographic atrophy, choroidal vasculopathy Polypoidal, so on.
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

Exclusion Criteria

-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-
-Patients at week 16 of the previous clinical trial show treatment response (losing 14 or Afewer letters in the ETDRS chart) in the treated eye, only a non-interventionist track that eye will be performed until week 48 after treatment delivery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified