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أخبار + رؤية المزيد

iStock-524390300-HR-CF94C8
23/04/2019.
Feliz Sant Jordi 2019
Pon a prueba tu visión y mira el tejado de la Casa Batlló. ...

خبر

56158414_2324345020949646_6241975867921137664_n
26/03/2019.
Awareness Campaign on Age-Related Macular Degeneration (AMD)
The Institut de la Mácula is undertaking a number of informative ...

خبر

foto_bona
13/03/2019.
Dr. Jordi Monés warns of the progression of AMD in a society that is living increasingly longer
The Director of the Institut de la Màcula played a leading role i...

خبر

_MG_8259
11/03/2019.
It is estimated that glaucoma affects over a million people in Spain
Early detection is vital for a disease that gives no warning and w...

خبر

البحث العلمي + رؤية المزيد

DMAE exsudativa (1)
09/04/2019.
Assaig clínic LUCERNE: Eficàcia i seguretat de FARICIMAB respecte d’aflibercept en el tractament de la degeneració macular associada a l’edat exsudativa


SI VOLS PARTICIPAR EN UN ASSAIG CLÍNIC, ENVIA'NS LES TEVES DADES AQUÍ I AVALUAREM SI ETS ELEGIBLE

Descripció

Aquest és un Assaig Clínic fase III, multicèntric, aleatoritzat, amb doble emmascarament, de dos grups paral·lels que avalua l'eficàcia i la seguretat de faricimab administrat a través d'injeccions intravítries en pacients amb degeneració macular associada a l’edat (DMAE) forma exsudativa en comparació amb el tractament amb aflibercept (EYLEA®).

Criteris d'inclusió principals

Pacients majors de 50 anys amb degeneració macular associada a l’edat exsudativa que no hagin rebut tractament per aquesta malaltia a l’ull d’estudi.

L'agudesa visual haurà d'estar compresa entre 20/32 i 20/320.

Objectiu

L'objectiu principal és demostrar l’eficàcia de faricimab en comparació amb aflibercept pel que fa al resultat d’agudesa visual a l’any de tractament

 Sobre el fàrmac

Faricimab és el primer anticòs monoclonal biespecific dissenyat per ús intravitri que combina l’acció antiangiogènica dels fàrmacs que s’utilitzen actualment pel tractament de la DMAE amb l’acció antiinflamatòria, neutralitzant alhora el VEGF i l’angiopoietina-2 . Els resultats en estudis previs donen suport a l'inici d'un assaig fase III per avaluar l'eficàcia i la seguretat de faricimab en el tractament de pacients amb DMAE neovascular, amb l’objectiu d’augmentar els intervals entre tractaments.

 Durada

Aquest assaig té una durada de dos anys.

SI VOLS PARTICIPAR EN UN ASSAIG CLÍNIC, ENVIA'NS LES TEVES DADES AQUÍ I AVALUAREM SI ETS ELEGIBLE

LaraTeixidor1

...

البحث العلمي تسجيل

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

 

...

البحث العلمي

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.

 

 

...

البحث العلمي

Multicolor
01/10/2018.
Clinical Trial OAKS and DERBY: Efficacy and safety of APL-2 in the treatment of 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

...

البحث العلمي

ساعدنا على وقف الأمراض البصرية التنكسية تقوم مؤسسة BMF بالبحث حول العلاجات الفعالة من أجل شفاء مزيد من حالات العمى. تعاون مع مؤسسة BMF برشلونة ماكولا فونديشن: البحث من أجل الرؤية

BMF-transp
Last modified: 24 April, 2019 - 8:54