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Clinical Trials/EUCTR2015-001812-36-ES
EUCTR2015-001812-36-ES
Active, not recruiting
Phase 1

Extension study for the follow up of patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulated controlled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1

Dr. Pedro Cuevas Sanchez (Investigacion Independiente)0 sites44 target enrollmentJune 15, 2015
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DrugsDICYNONE 250 mg/2 ml, solution injectable

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. Pedro Cuevas Sanchez (Investigacion Independiente)
Enrollment
44
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2015
End Date
September 15, 2017
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dr. Pedro Cuevas Sanchez (Investigacion Independiente)

Eligibility Criteria

Inclusion Criteria

  • •\-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

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

Outcomes

Primary Outcomes

Not specified

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