Aged related macula degeneration (ARMD)
Conditions
Sponsors
Investigacion Independiente
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 16- 48 weeks;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. This objective will be valued only in patients not receiving intravitreal ethamsylate in the extension study.;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 -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 to revert the structural changes in the retina associated to ARMD -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 in the contrast sensibility -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 on the quality of life of patients. Safety: -Incidence of serious and severe adverse events related with the intravitreal ethamsylate (1 or 2 doses) or simuled treatment during the participation in the study. -Evaluate the changes in the intraocular pressure after the intravitreal ethamsylate injections(1 or 2 doses) or simuled treatment and its evolution during the participation in the 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Treated Eye. week 4 to week 16 No treated Eye: Week 16-week 48;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. | — |
Countries
Spain
Contacts
Public ContactRocio Garcia Cañamaque
Leon Research S.L.
Outcome results
None listed