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What sets us apart? 

360º MEDICINE

Alongside medical rigour we offer additional benefits, providing all our patients with comprehensive care through a programme of exclusive services at no extra cost.

  • Psychological support.
  • Nutritional counselling.
  • Advice on assistive technologies.
  • Patient accompaniment service.
Among other services. + See more

News + See all news items

DMAE atrofica 2 (RGB)
16/10/2020.The Institut announces study using postbiotics in AMD patients
Javier Asarta, CEO of the Igen Biolab Group: “AMD affects some 700,000 peo...

News

Corona virus: vial with pipette in laboratory
26/06/2020.
MARCADORES SEROLÓGICOS PARA EL DIAGNÓSTICO DE COVID-19
El Institut de la Màcula, junto con el laboratorio SYNLAB, realiza ...

News

a8046015ce41433bee06b10af7db0ceed5066e2c774f8379a21a4ab50bdc3e60
29/05/2020.New care circuit for Covid-19 patients and special measures for attending to the vulnerable
With the aim of protecting both you and us, we have designed a NEW CARE CIRCUIT...

News

Foto portada equip
25/05/2020.
El equipo del Institut de la Màcula te da las gracias!
 El Dr. Jordi Monés y todo el equipo del Institut de la Màcula en e...

News

Research + See all research

retinosi pigmentaria
18/11/2020.Phase I/IIa study in subjects with Retinitis Pigmentosa


Description

A first, prospective, open, phase I/IIa human study of the safety and tolerability of human retinal progenitor cells (hRPC) transplanted into the subretinal space in subjects with Retinitis Pigmentosa (RP).

This is a prospective open phase I/II study to treat RP patients with transplanted human retinal progenitor cells. Participants will only be treated in one eye.

Main inclusion criteria

Adult men and women who are healthy (apart from their retinitis pigmentosa)

Patients’ visual acuity should be between 20/50 and 20/800 and be similar in both eyes

Aim

The aim of the study is to determine the safety and tolerability of human retinal progenitor cell transplantation in RP patients.

About the treatment

Subretinal stem cell injection in one eye. All the participants will receive the treatment and this will only be in one eye.

FREQUENTLY ASKED QUESTIONS

Who can participate in this clinical trial?

This clinical trial is aimed only at patients who have been diagnosed with RP and whose vision is between 20/50 and 20/800 and similar in both eyes.

What are the benefits and risks of participating in a trial?

Participation in a clinical trial offers a number of advantages for patients: they have the chance to access the most innovative treatments, with personalised and state-of-the-art care from medical experts. In addition, this is currently the only way to access new treatments that are not yet available to the general public.

Clinical trials are conducted according to strict ethical and scientific principles. At the Institute, we apply national and international standards and policies in order to protect the rights, safety and well-being of those who participate in them.

The risks of participation in a clinical trial may arise from the route of administration of the drug on the one hand and from the medication on the other. The risks of the former are better known; the treatment derivatives (in this case, the subretinal injection of human retinal progenitor cells) are partially known. In any case, the patient will be informed by the researcher of the possible adverse effects and discomforts resulting from their participation in the study, which may vary from one patient to another.

How much does it cost the patient?

Nothing

How long is the clinical trial?

The duration of this study is 24 months.

How many times do I need to go to the Institut de la Mácula?

After being selected to take part in this clinical trial, the patient must make 17 visits, which are scheduled according to the study protocol.

 

 

 

...

Research

KODIAC2
18/11/2020.KODIAK: A phase II study in patients with the exudative form of AMD

Description

KODIAK KSL-CL-102: A phase II, prospective, randomised study with double masking of two groups. It assesses the efficacy and safety of repeated intravitreal administration of KSI-301 5mg compared to aflibercept 2mg in patients with the exudative form of age-related macular degeneration (AMD).

Main inclusion criteria

Patients of 50 and above with active choroidal neovascularisation secondary to AMD and who have not received any previous treatment in the study eye.

Visual acuity should be between 80 and 25 letters (approximate Snellen equivalent of 20/25 to 20/320).

Aims

To demonstrate that treatment with KSI-301 5mg is not inferior to using aflibercept 2mg with respect to the change in visual acuity from the baseline visit to the one made after the first year of treatment.

The drug

Vascular endothelial growth factor (VEGF) is a glycoprotein with a trophic and proliferative role, promoting the growth of new filtering and abnormal blood vessels in the retina in patients with exudative AMD.

KSI-301 is a new molecular entity (NME) formed by an antibody biopolymer conjugate and is responsible for the inhibition of the VEGF. Therefore, KSI-301 acts primarily as an antiangiogenic and anti-permeabilising agent, which brings a clinical benefit in VEGF-mediated disorders, such as exudative AMD.

This NME is designed to improve visual acuity with an extended intraocular half-life and longer treatment intervals in comparison to other intravitreal medications.

Previous studies in humans have shown that a single administration of 1.25mg, 2.5mg or 5mg of KSI-301 was safe and tolerable in subjects with diabetic macular oedema (DMO). Based on the observed tolerability and activity of the single dose, the highest dose of KSI-301 tested in the Phase 1 study (5mg) was selected for this Phase 2 study on exudative AMD.

Duration

The duration of this trial is two years.

KODIAC

...

Research Recruiting

entrev autofluo DMAE atrofica (RGB)
18/11/2020.REVERS: Study using postbiotics in AMD patients

DESCRIPTION

A study to assess the efficacy and safety of postbiotic supplementation in

1) Preventing AMD progression, its impact on the worsening of functional and anatomical assessment criteria in intermediate age-related macular degeneration (iAMD)

2) Slowing the progression rate of geographic atrophy (GA) in patients with late non-exudative AMD or macular dystrophies.

3) Improving the efficacy of antiangiogenic therapy in patients with choroidal neovascularisation and insufficient response to treatment.

Depending on the treatment group, subjects will be randomly assigned an approved nutritional supplement for the prevention of the progression of intermediate AMD (AREDS) or the same supplement enriched with postbiotics.

INCLUSION CRITERIA 
Patients older than 50 with intermediate AMD, geographic atrophy and choroidal neovascularisation in antiangiogenic treatment and with weak treatment response.

ABOUT THE SUPPLEMENT 
Postbiotics are compounds that are usually secreted by bacteria that live in our intestine. They may have direct and clinically relevant immunomodulatory effects. Studies may be found on the use of postbiotics in healthy individuals to improve overall health or to relieve symptoms in various diseases.

DURATION
The duration of the study will be one year, with a possible two-year extension.

+ More information

 

 

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Research Recruiting

Identificació mitjançant SD-OCT d’una drusa que comença el procés d’atròfia. A) S’observa una drusa sense irregularitats, però amb hiper-reflectivitat en el RPE superposat. B) El RPE mostra irregularitats i punts hiper-reflectius per sobre. C) Els danys en el RPE són més evidents amb la presència de punts iso-reflectius — el drusen ooze.
18/11/2020.ISEE2008: Phase III clinical trial in patients with dry AMD


DESCRIPTION

ISEE2008 (GATHER2): A multicentre, randomised, double-masked, simulation controlled phase III clinical trial to assess the safety and efficacy of the intravitreal administration of Zimura (C5 complement inhibitor) in patients with geographic atrophy secondary to dry age-related macular degeneration

INCLUSION CRITERIA

Patients older than 50 with non-foveal geographic atrophy secondary to dry age-related macular degeneration. They should not have received prior treatment or have exudative macular degeneration in the other eye. Vision should be between 20/25 and 20/320.

AIMS

The aims of this study are to assess the safety and efficacy of the intravitreal administration of Zimura in patients with geographic atrophy secondary to dry age-related macular degeneration (AMD).

DURATION 
The duration of the study is 2 years.

 

...

Research Recruiting

International patients

Do you live outside Barcelona but would like to be treated at the Institut de la Màcula? Enter here and find all the information you need.

Help us prevent degenerative eye diseases. The BMF researches effective treatments to reverse ever more forms of blindness. Collaborate with the Barcelona Macula Foundation: Research for Vision

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Last modified: 25 November, 2020 - 13:28