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  • خدمات مرافقة
إضافة إلى خدمات أخرى + للمزيد

أخبار + رؤية المزيد

Closeup portrait of young women with glasses. She has eyesight problems and is squinting his eyes a little bit. Beautiful girl is holding eyeglasses right in front of camera with two hand
11/07/2019.
What is myopia? Who is affected by myopia? What causes myopia?
What is myopia? ...

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02/07/2019.
Living with AMD: two stories in search of light
...

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27/06/2019.
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The microbiome is the set of microorganisms that live...

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21/06/2019.
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With St John’s Night here again, we at the Institut de la Màcul...

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البحث العلمي + رؤية المزيد

DMAE exsudativa (1)
09/04/2019.
LUCERNE clinical trial: efficacy and safety of FARICIMAB regarding aflibercept in the treatment of exudative age-related macular degeneration

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND I WILL EVALUATE IF YOU ARE ELIGIBLE

Description

This is a multicentre, randomized and double-masking Clinical Trial Phase III of two parallel groups that evaluates the efficacy and safety of faricimab administered by intravitreal injeccions in patients with exudative age-related macular degenereation (AMD) compared to treatment with aflibercept (EYLEA®).

 Main inclusion criteria

Patients over 50 years of exudative age-related macular degeneration who have not received study’s treatment for this eye disease

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

 Goal

The main objective is to demonstrate the efficacy of faricimab compared with aflibercept regarded the visual acuity result one year later

About the medicine

Faricimab is the first bispecific monoclonal antibody designed for intravitreal use that combines the antiangiogenic action of the medicine currently used for the AMD’s treatment with the anti-inflammatory action, neutralizing VEGF and angiopoietin-2 at the same time. The results in previous studies support the beginning of a Phase III trial to evaluate the efficacy and safety of faricimab in the treatment of neovascular AMD patients, in order to increase the intervals between treatments.

 Duration

This essay lasts for two years.

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND I WILL EVALUATE IF YOU ARE ELIGIBLE

...

البحث العلمي تسجيل

AGF-DME
03/03/2019.
RHINE – Phase III study in the treatment of diabetic macular oedema

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND I WILL EVALUATE IF YOU ARE ELIGIBLE

Description:

This is a phase III, multi-centre, randomised, double-masked, three-group trial that assesses the efficacy and safety of RG7716 administered through intravitreal injections in adult patients with visual disturbance due to diabetic macular oedema (DMO) in comparison with the administration of aflibercept (EYLEA®).

Principal inclusion criteria:

Patients of over 18 years of age with type 1 or 2 diabetes mellitus and visual disturbance due to diabetic macular oedema in the study eye without previous treatment with any anti-VEGF drug or who have not received it in the past three months.

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

Aim:

The main aim is to demonstrate that RG7716 is not inferior to aflibercept with respect to visual outcome after the first year of treatment.

About the drug:

RG7716 is an antibody that inhibits for the first time and simultaneously two factors, VEGF-A and Angiopoietin 2, producing a priori improved control of the mechanisms that induce diabetic macular oedema.

Duration:

This trial has a duration of two years.

*Institut Registration Code: E08607500. Clinical trial authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the CEIm of the Quironsalud Hospital Group in Barcelona.

IF YOU WANT TO PARTICIPATE IN A CLINICAL TRIAL, SEND US YOUR DATA HERE AND I WILL EVALUATE IF YOU ARE ELIGIBLE

...

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 تسجيل

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: 21 July, 2019 - 21:34