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Научно-исследовательский центр и прием пациентов

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Доктор Джорди Монэс, MD, PhDДиректор

Институт под управлением Доктора Джорди Монэса

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17/10/2018.
The Institut de la Màcula launches free screening to detect vision problems linked to diabetes
High-precision diagn...

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Examination at optician's offfice.
10/10/2018.
World Sight Day 2018
World Sight Day 2018, which falls on 11 October, aims to make the pop...

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_MG_8195
27/09/2018.
World Day of the Elderly 2018
Monday, 1 October 2018, marks World Day of th...

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Fighting Blidness-082
23/09/2018.
Dr. Jordi Monés participates at the 18th EURETINA Congress
Dr. Jordi Monés, the Director of the ...

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_MG_8267
16/09/2018.
World Retinitis Pigmentosa Day 2018
Sunday, 30 September 2018 marks World Retinitis Pigmentosa Day...

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Блог

Исследования + подробнее

EMD_OCT negre
03/10/2018.THR-317-002: Clinical trial for the treatment of Diabetic Macular Oedema

Description

A randomized, single-masked, multicenter, phase II clinical trial to evaluate the safety and efficacy of a new treatment, THR-317 (8 mg), in combination with ranibizumab 0.5 mg, vs sham THR-317 injection and ranibizumab 0.5 mg, in patients with diabetic macular edema (DME).

Inclusion criteria

Patients with central DME without previous anti-VEGF treatment or with poor response to previous treatment with ranibizumab 0.5 mg. according to specific criteria.

Aim

To determine the safety and efficacy of THR-317 (8 mg) in combination with ranibizumab 0.5 mg as evaluated by best-corrected visual acuity change at month 3 as compared to baseline.

About the drug

THR-317 is an immunoglobulin G recombinant humanized monoclonal antibody directed against the Placental Growth Factor (PlGF) receptors types 1 and 2.

Who can participate

Patients with types 1 or 2 diabetes mellitus and DME with a visual acuity between 20/40 and 20/320, and without previous anti-VEGF treatment or with a poor response (as defined in the Protocol) to ranibizumab 0.5 mg. after a minimum of 3 intravitreal injections, the last one of which should have taken place 1 year previous to the screening visit as maximum. Further criteria apply.

Study duration

Approximately 5 months (140 days)

If you are interested in taking part in a clinical trial, please send us your personal details here and we will assess whether you are eligible.

 

PilarRuiz_red1

 

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Исследования наем

kestrel_horizontal
03/10/2018.
Clinical Trial KESTREL: Efficacy and safety of brolucizumab in comparison with aflibercept in diabetic macular edema

 

Description

This is a phase III, multi-centre, randomised, double-masked, three-group clinical trial that evaluates the efficacy and safety of Brolucizumab administered through intravitreal injections in adult patients with visual disturbance due to diabetic macular edema (DME) in comparison with the administration of aflibercept (EYLEA®).

Main inclusion criteria

Patients ≥18 years old with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular edema in the study eye without previous treatment with any anti-VEGF drug.

Visual acuity should be between 20/32 and 20/320.

Aim

The main aim is to demonstrate that brolucizumab is not inferior to aflibercept with respect to visual outcome after the first year of treatment.

About the drug

The findings in previous trials support the start of a phase III programme to evaluate the efficacy and safety of brolucizumab in the treatment of patients with visual disturbance due to DME with the intention of assessing the possibility of reducing treatment burden for patients.

Duration

This trial has a duration of two years.

If you are interested in taking part in a clinical trial, please send us your personal details here and we will assess whether you are eligible.

ClaraRamon1

 

FREQUENTLY ASKED QUESTIONS

Who can take part in this clinical trial?

Patients ≥18 years old with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular edema in the study eye without previous treatment with any anti-VEGF drug.

Visual acuity should be between 20/32 and 20/320.

What are the benefits/risks of taking part in a trial

Participation in a clinical trial offers patients a series of advantages: the new treatment gives them the chance to receive state-of-the-art medical care from experts. This is, for the time being, also the only means of access to new drugs which are not available to

Clinical trials are performed in accordance with strict ethical and scientific principles. We at the Institut apply national and international standards and policies in protection of the rights, safety and welfare of participants.

The risks of participation in a clinical trial may derive from the route of administration of the drug on the one hand and the medication on the other. The risks of the former are well-known and generally low; those deriving from the medication are only partially known but are habitually low and restricted to the eye. In any case, the patient will be informed by the investigator of the possible adverse effects and discomfort resulting from his/her participation in the study. These may vary from one patient to another.

Do patients need to pay?

The patients chosen for clinical trials are not charged for treatment and therefore it is completely free of charge.

How long will the trial last?

The duration will be 24 months.

How many times will I have to attend to the Institut de la Màcula?

Once selected to be part of this clinical trial, the patient will have to compulsorily attend the visits scheduled by the study protocol.

 

 

...

Исследования наем

Multicolor
01/10/2018.
Clinical Trial: Apellis in patients with geographic atrophy secondary to AMD

Description

A randomized, double-masked, multicenter, phase III clinical trial to evaluate the safety and efficacy of a new treatment, APL-2, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Inclusion criteria

Patients with 60 years or older with GA and without concomitant or previous neovascular (wet) AMD. Further eligibility criteria applies.

Aim

To establish the safety and efficacy of APL-2 as determined mainly by change in GA lesion size at month 12 as compared to baseline in treated vs untreated patients.

About the drug

APL-2 (15 mg/0.1 ml) is an inhibitor of Complement protein C3 delivered by intravitreal injection.

Who can participate

Patients with GA secondary to AMD with a visual acuity in the study eye equal or better than 20/320 and a lesion size between 2.5 and 17.5 mm2, who have no current or prior history of wet AMD and who have not received treatment for wet AMD.

Study duration

30 months.

IF YOU ARE INTERESTED IN TAKING PART IN A CLINICAL TRIAL, PLEASE SEND US YOUR PERSONAL DETAILS HERE AND WE WILL ASSESS WHETHER YOU ARE ELIGIBLE.

ClaraRamon1

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Исследования

STARGARDT_BN
10/05/2018.Clinical trial OPH2005: Efficacy and safety of Zimura in the treatment of Stargardt’s disease

Description

OPH2005 is a randomised, double-masked phase 2b study to establish the efficacy and safety of Zimura™ compared with placebo in subjects diagnosed with Stargardt’s disease inherited in an autosomal recessive manner.

The patients will be randomly assigned to different groups.

Inclusion criteria

Men and women between 18 and 50 years old with a minimum of two pathogenic mutations in the gene ABCA4 that will be confirmed by the study laboratories.

The visual acuity of patients should be between 20/20 and 20/200.

Aim

The study aim of the study is to assess mean rate of change in the area of ellipsoid zone defect as measured by OCT.

About the drug

Zimura is designed to inhibit C5 complement protein.

Zimura binds to and inhibits C5 being cleaved into C5a and C5b, potentially preventing the formation of inflammasomes and the accumulation of the membrane attack complex (MAC), which would prevent cell death.

If you are interested in taking part in a clinical trial, please send us your personal details here and we will assess whether you are eligible.

 

FREQUENTLY ASKED QUESTIONS

Who can take part in this clinical trial?

Subjects diagnosed with Stargardt’s disease between 18 and 50 years old with a minimum of two pathogenic mutations in the gene ABCA4 and whose visual acuity must be between 20/20 and 20/200. Moreover, the patients cannot present any other eye disease.

What are the benefits/risks of taking part in a trial?

Participation in a clinical trial offers patients a series of advantages: the new treatment gives them the chance to receive state-of-the-art medical care from experts. This is, for the time being, also the only means of access to new drugs which are not available to
Clinical trials are performed in accordance with strict ethical and scientific principles. We at the Institut apply national and international standards and policies in protection of the rights, safety and welfare of participants.
The risks of participation in a clinical trial may derive from the route of administration of the drug on the one hand and the medication on the other. The risks of the former are well-known and generally low; those deriving from the medication are only partially known but are habitually low and restricted to the eye. In any case, the patient will be informed by the investigator of the possible adverse effects and discomfort resulting from his/her participation in the study. These may vary from one patient to another.

Do patients need to pay?
The patients chosen for clinical trials are not charged for treatment and therefore it is completely free of charge

How long will the trial last? 

The duration will be 18 months.

How many times will I have to attend to the Institut de la Màcula?

Once selected to be part of this clinical trial, the patient will have to compulsorily attend the visits scheduled by the study protocol.
These visits will have a fortnightly periodicity during the first three months and monthly from the third month until the end of the study.

LaraTeixidor1

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Исследования наем

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Last modified 18 October, 2018 - 10:59