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Dr Jordi Monés MD, PhDDirector

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29/06/2018.Dr. Marta Pazos appears on Catalunya Ràdio to instruct the population about the dangers of tobacco
Dr. Marta Pazos, the ophthalmologist at the Institut de la Màcula and a glaucoma specialist, w...

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29/06/2018.Dr. Jordi Monés tells Ser Catalunya of the dangers of firecrackers for eyesight
Dr. Jordi Monés, the Director of the Institut of the Mácula, has explained to the new...

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22/06/2018.The Institut de la Màcula recommends protecting eyes to enjoy a safe St. John’s Eve
The summer solstice brings with it the St John’s Eve festivities, a public celebration that h...

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20/06/2018.The Institut de la Màcula sets out the latest developments in the field of degenerative visual diseases at the WOC
Dr. Jordi Monés, MD, PhD, the Director del Institut de la Màcula and a renow...

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08/06/2018.The Institut de la Màcula, a pioneer in treatments to cure or halt the loss of vision
The Institut de la Màcula is a benchmark centre specialising in medical and s...

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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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Research Recruiting

Bacteria closeup
03/08/2017.The Microbiome Project: microbiota associated to Macula Diseases – µMD

 

The microbiome comprises microorganisms that live in or on the human body. There are a growing number of studies that link the microbiome to metabolic disorders through modulation of the inflammation, including inflammatory bowel disease, cancer, HIV/AIDS, schizophrenia and ageing.

With regard to the eye, the study of the microbiome relates principally to dry eye and autoimmune uveitis. Unfortunately, its role in Age-Related Macular Degeneration (AMD), the leading cause of blindness in developed countries in the over-50s, or in other eye disorders, has not been widely studied.

The Barcelona Macula Foundation (BMF), in conjunction with the Centre of Genomic Regulation (CRG) and the Institut de la Màcula (IM), will undertake the Microbiome Project in order to study the microbiome. The aim is to shed light on the mechanisms of AMD and to open up new channels for the creation of new therapies.

To do so, we will obtain stool samples from patients who attend the IM and who have a range of eye disorders. This will enable us to determine the association between gut microbiome and eye disease.

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Research Recruiting

bjophthalmol-2017-310268-F2.large
28/07/2017.Geographic atrophy phenotype identification by cluster analysis
Monés J, Biarnés M. Geographic atrophy phenotype identification by cluster analysis. British Journal of Ophthalmology Published Online First: 20 July 2017. doi: 10.1136/bjophthalmol-2017-310268

 

http://bjo.bmj.com/content/early/2017/07/19/bjophthalmol-2017-310268

 

Background/aims To identify ocular phenotypes in patients with geographic atrophy secondary to age-related macular degeneration (GA) using a data-driven cluster analysis.

Methods This was a retrospective analysis of data from a prospective, natural history study of patients with GA who were followed for ≥6 months. Cluster analysis was used to identify subgroups within the population based on the presence of several phenotypic features: soft drusen, reticular pseudodrusen (RPD), primary foveal atrophy, increased fundus autofluorescence (FAF), greyish FAF appearance and subfoveal choroidal thickness (SFCT). A comparison of features between the subgroups was conducted, and a qualitative description of the new phenotypes was proposed. The atrophy growth rate between phenotypes was then compared.

Results Data were analysed from 77 eyes of 77 patients with GA. Cluster analysis identified three groups: phenotype 1 was characterised by high soft drusen load, foveal atrophy and slow growth; phenotype 3 showed high RPD load, extrafoveal and greyish FAF appearance and thin SFCT; the characteristics of phenotype 2 were midway between phenotypes 1 and 3. Phenotypes differed in all measured features (p≤0.013), with decreases in the presence of soft drusen, foveal atrophy and SFCT seen from phenotypes 1 to 3 and corresponding increases in high RPD load, high FAF and greyish FAF appearance. Atrophy growth rate differed between phenotypes 1, 2 and 3 (0.63, 1.91 and 1.73 mm2/year, respectively, p=0.0005).

Conclusion Cluster analysis identified three distinct phenotypes in GA. One of them showed a particularly slow growth pattern.

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Publication

Fig 01 ooze
24/04/2017.Drusen Ooze: A Novel Hypothesis in Geographic Atrophy

Monés J, Garcia M, Biarnés M, Lakkaraju A, & Ferraro L. (2017). Drusen Ooze: A Novel Hypothesis in Geographic Atrophy. Ophthalmology Retina.

http://www.ophthalmologyretina.org/article/S2468-6530(16)30172-5/fulltext

Purpose

To describe a subgroup of subjects with soft drusen associated with geographic atrophy (GA) and novel spectral-domain OCT (SD-OCT) findings consistent with presumed drusen leakage. We also propose a mechanism leading to GA progression in these patients.

Design

A retrospective, observational cohort study.

Participants

Forty-eight eyes of 33 patients with soft drusen secondary to age-related macular degeneration (AMD).

Methods

Drusen were evaluated with SD-OCT and retinal imaging to characterize the development of atrophy-associated drusen regression (drusen collapse) over a follow-up period of ≥18 months.

Main Outcome Measures

The presence of isoreflective dots at the outer retinal layers associated with retinal pigment epithelium (RPE) defects. Percentages of previously reported hyperreflective RPE, and hyperreflective dots (HRDs) were also determined.

Results

Nineteen of 48 eyes (39.6%) showed a collapse of ≥1 druse during the follow-up period. Thirty-four foci of collapsed drusen were found to be associated with either isoreflective dots associated with RPE defects (32.4%), hyperreflectivity of the RPE (91.2%), or HRDs (79.4%). A post hoc showed the adjusted odds ratio of drusen collapse for isoreflective dots (65.8), for HRDs (6.0) or both (12.1).

Conclusions

In soft drusen progressing to subsequent atrophy, approximately 33% were associated with isoreflective dots and RPE defects. In addition, overlying hyperreflectivity of the RPE and HRDs were noted with high frequency. Presence of isoreflective dots, with or without HRDs, was associated with a strong risk of developing atrophy compared with drusen without these findings. We hypothesize that these isoreflective dots associated with RPE defects may be debris extruded from the soft drusen into the subretinal space, which we have termed “drusen ooze”. Drusen ooze may activate the RPE apical surfaces, leading to a marked increase in phagocytosis/endocytosis of extracellular debris that eventually overwhelms the RPE capacity, and leads to RPE death, subsequent release of intracellular RPE material and thereby propagate a cycle of cellular death resulting in GA development and progression. Therapeutic targeting of drusen material, prior to its extrusion into the subretinal space and prior to irreversible damage to the RPE, might prevent or delay onset and progression of GA.

 

 

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Publication

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Last modified 18 September, 2018 - 11:17