FASE IV-II CLINICAL TRIAL, PROOF OF CONCEPT, RANDOMIZED, SIMULATED AND BLINDED CONTROLLED TREATMENT, WITH TWO GROUPS, IN ONE HOSPITALTO EVALUATE SAFETY AND EFFICACY OF A DRUG ADMINISTERED VIA A NEEDLE IN THE EYE TO IMPROVE THE VISUAL ACUITY IN PATIENTS WITH AGE RELATED MACULA DEGENERATION.

FASE IV-II CLINICAL TRIAL, PROOF OF CONCEPT, RANDOMIZED, SIMULATED CONTROLLED TREATMENT, DOUBLE BLINDED AND UNICENTRIC WITH TWO PARALLEL GROUPS, TO EVALUATE SAFETY AND EFFICACY OF INTRAVITREAL ADMINISTRATION OF ETAMSILATO IN THE IMPROVEMENT OF VISUAL ACUITY IN PATIENTS WITH AGE RELATED MACULA DEGENERATION.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005259-20-ES

Enrollment

160

Registered

2015-01-16

Start date

2015-02-13

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged related macula degeneration (ARMD) MedDRA version: 17.1 Level: PT Classification code 10025409 Term: Macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: DICYNONE 250 mg/2 ml, solution injectable Pharmaceutical Form: Solution for injection INN or Proposed INN: Etamsylate CAS Number: 2624-44-4 Other descriptive name: ETAMSYLATE Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Both genders adult patients (more than 18 years old) - Dry or wet ARMD, diagnosed within a maximum period of 2 years before - Best visual acuity corrected between 20/25 and 20/320, evaluated with optotype ETDRS - 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: - Grade 5 ARMD - Have any ophthalmological disease that, based on the investigator judgment could interfere in the development, evolution or valoration of the ARMD, as glaucoma, permanent structural illness in the core of the fovea, para foveolar geographic atrophy, polipoideal carotids vasculitis, etc - 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. - Received treatment in the previous month with any other intravetreal anti-VEGF drug in the last 3 months - Pregnant or breast- feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Stablish the efficacy after 4 weeks of a unique intravitreal injection with Etamsilato in the improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease;Secondary Objective: Efficacy - Evaluate the Efficacy after 16 weeks of a unique intravitreal injection of Etamsilato in the improvement of the visual acuity in patients diagnosed of dry or wet ARMD - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato to revert the structural changes in the retina associated to ARMDafter 4 and 16 weeks of treatment - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato in the improvement of the contrast sensibility evolution after 4 and 16 weeks of treatment - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato on the quality of life of patients after 4 and 16 weeks of treatment Safety - Incidence of Serious and severe Adverse Events related with the intravitreal etamsylato during 16 weeks after the unique injection - Evaluate the changes in the intraocular pressure after the intravitreal etamsylato injection and the during 16 weeks after the unique injection;Timepoint(s) of evaluation of this end point: 4-16 weeks;Primary end point(s): Primary objective variable - Rate of success of treatment for patients in the 4 weeks after the intravitreal administration of etamsilato - Furthermore, if some requisites are fulfilled, the evolution, from the baseline visit up to week 4, of the best visual acuity corrected obtained with the ETDRS optptype and using logarithmic value (logMAR) equivalent to the number of letters correctly read, will be evaluated as co-principal criteria	—

Measure

Time frame

Main Objective: Stablish the efficacy after 4 weeks of a unique intravitreal injection with Etamsilato in the improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease;Secondary Objective: Efficacy - Evaluate the Efficacy after 16 weeks of a unique intravitreal injection of Etamsilato in the improvement of the visual acuity in patients diagnosed of dry or wet ARMD - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato to revert the structural changes in the retina associated to ARMDafter 4 and 16 weeks of treatment - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato in the improvement of the contrast sensibility evolution after 4 and 16 weeks of treatment - Evaluate the Efficacy of a unique intravitreal injection of Etamsilato on the quality of life of patients after 4 and 16 weeks of treatment Safety - Incidence of Serious and severe Adverse Events related with the intravitreal etamsylato during 16 weeks after the unique injection - Evaluate the changes in the intraocular pressure after the intravitreal etamsylato injection and the during 16 weeks after the unique injection;Timepoint(s) of evaluation of this end point: 4-16 weeks;Primary end point(s): Primary objective variable - Rate of success of treatment for patients in the 4 weeks after the intravitreal administration of etamsilato - Furthermore, if some requisites are fulfilled, the evolution, from the baseline visit up to week 4, of the best visual acuity corrected obtained with the ETDRS optptype and using logarithmic value (logMAR) equivalent to the number of letters correctly read, will be evaluated as co-principal criteria

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 4-16 weeks;Secondary end point(s): Secondary objective variable - Rate of success of treatment for patients in the week 16 after the intravitreal administration of etamsylate - Evolution, from the baseline visit up to week 16 of the best visual acuity corrected with the ETDRS optotype and using units logMAR equivalent to the total number of letters correctly read - Evolution, from the baseline visit up to week 4 and week 16, of the number of letters correctly read (counting from the upper left corner) with the ETDRS optotype - Evolution, from the baseline visit up to week 4 and week 16, of the best visual acuity corrected obtained with the Snellen optotype and using units logMAR adjusted to the total number of letters correctly read - Rate of success of treatment for patients at week 4 and at week 16 after the intravitreal administration of etamsylate - Rate of patients improving the visual acuity corrected more or equal to 15 letters with the ETDRS optptype. - Only for a subset of wet ARMD: Rate of patients with success of treatment and a decrease of the edema in the core of the macula, with a similar thickness in micro metres, at week 4 and at week 16. - Evolution of the thickness in the central part of the macula measured by OCT - Evolution of the number of focused areas of pigment epithelium disappearance measured with OCT - Evolution of the Scotoma size measured by micro perimetry - Evolution of the number, location, area and volume of the drusen measured by OCT and colored retinography. - Evolution of the sensitivity to contrast determined through Pelli-Robson tables - Evolution of patient quality of life measured with the Visual Function Questionnaire-25 of the National Eye Institute (VFQ-25) and the EuroQoL 5 dimensions (EQ-5D)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 4-16 weeks;Secondary end point(s): Secondary objective variable - Rate of success of treatment for patients in the week 16 after the intravitreal administration of etamsylate - Evolution, from the baseline visit up to week 16 of the best visual acuity corrected with the ETDRS optotype and using units logMAR equivalent to the total number of letters correctly read - Evolution, from the baseline visit up to week 4 and week 16, of the number of letters correctly read (counting from the upper left corner) with the ETDRS optotype - Evolution, from the baseline visit up to week 4 and week 16, of the best visual acuity corrected obtained with the Snellen optotype and using units logMAR adjusted to the total number of letters correctly read - Rate of success of treatment for patients at week 4 and at week 16 after the intravitreal administration of etamsylate - Rate of patients improving the visual acuity corrected more or equal to 15 letters with the ETDRS optptype. - Only for a subset of wet ARMD: Rate of patients with success of treatment and a decrease of the edema in the core of the macula, with a similar thickness in micro metres, at week 4 and at week 16. - Evolution of the thickness in the central part of the macula measured by OCT - Evolution of the number of focused areas of pigment epithelium disappearance measured with OCT - Evolution of the Scotoma size measured by micro perimetry - Evolution of the number, location, area and volume of the drusen measured by OCT and colored retinography. - Evolution of the sensitivity to contrast determined through Pelli-Robson tables - Evolution of patient quality of life measured with the Visual Function Questionnaire-25 of the National Eye Institute (VFQ-25) and the EuroQoL 5 dimensions (EQ-5D)

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Countries

Spain

Contacts

Public ContactRocio Garcia Cañamaque

León Research S.L.

rgcanamaque@leonresearch.es0034987261064

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026