Aged related macula degeneration (ARMD)
Conditions
Sponsors
Dr. Pedro Cuevas Sanchez (Investigacion Independiente)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who show "response to treatment" (lose 15 or more letters in the ETDRS chart) in the "treated eye"at 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of treatment received in the previous clinical trial (intravitreal ethamsylate or simulated treatment) in improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease after a non-interventionist tracking "treated eye" in the clinical trial until the week 48 of the double blinded treatment administration. ;Secondary Objective: -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 : -Regarding efficacy in improvement visual acuity in patients diagnosed of dry or wet ARMD -To revert the structural changes in the retina associated to ARMD -In the contrast sensibility -On the quality of life of patients. Safety: -Incidence of serious and severe adverse events related to their severity with the intravitreal ethamsylate (1 or 2 doses) or simuled treatment during the participation in the retreatment study. -Evaluate the changes in the intraocular pressure after the intravitreal ethamsylate injections(1 or 2 doses) and its evolution during the participation in the retreatment study. ;Primary end point(s): Criteria for evaluation of effectiveness -Rate of success of treatment for treated eyes in the 4,16,24,36 weeks after the double blinded treatment (with or without second injection) or after the open and active treatment of the contralateral eye. -Rate of success of treatment for treated eyes in the 4,16,24,36 weeks after the double blinded treatment (with or without second injection) or after the open and active treatment of the contralateral eye. -Time to the disappearance of the response. -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the best visual acuity corrected with the ETDRS optotype and using logarithmic value (logMAR) equivalent to the number of letters correctly read | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Criteria for evaluation of safety: -Incidence of serious and severe adverse events related with the intravitreal ethamsylate during the participation in the extension study. -Evolution of intraocular pressure in treated eyes during the participation in the extension study.;Timepoint(s) of evaluation of this end point: 16- 48 weeks | — |
Countries
Spain
Contacts
Public ContactRocio Garcia Cañamaque
Leon Research S.L.
Outcome results
None listed