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أخبار + رؤية المزيد

bengala
23/06/2022.
Pyrotechnics: caution, protection and distance
We at the Institut de la Màcula want to focus on the eye injuries tha...

خبر

pentacam axl wave
09/05/2022.
The Institut de la Màcula incorporates state-of-the-art diagnostic equipment for corneal refractive surgery and premium cataract surgery
When approaching surgery, it is essential to have precise measurements...

خبر

Young tired working woman at work
20/04/2022.
How to deal with allergic conjunctivitis
Allergic conjunctivitis usually presents in the spring, although it ca...

خبر

Míriam Garcia i Marc Biarnés
24/03/2022.
Clues on the posterior segment for non-ophthalmologist healthcare professionals
Marc Biarnés and Míriam Garcia, opto...

خبر

البحث العلمي + رؤية المزيد

Distrofia coroidea areolar central
15/02/2022.
RADIS: Observational Study of Rare Retinal Pathologies

Description

RADIS is an observational study focused on rare eye diseases whose main objective is to characterize the natural history of some of these pathologies. The diseases included in the study are very rare and currently have no treatment.

RADIS is an exclusive study of the Institut de la Màcula.

Inclusion criteria

Adult patients with rare ocular diseases that affect the posterior segment (retina, choroid, vitreous and optic nerve) capable of carrying out the required tests and signing informed consent.

Exclusion criteria

Patients with other concomitant pathologies of the posterior segment, taking medication that may induce known toxicity to the retina or optic nerve, with previous intraocular surgery (other than cataract surgery), corneal or glaucoma surgery, and those who are participating in a clinical trial for an eye disease or who have done so in the last 12 months.

Duration

Two years.

Recruitment period

Until December 31, 2022.

...

البحث العلمي تسجيل

retinosi pigmentaria
18/11/2020.
Phase I/IIa study in subjects with Pigmentary Retinosis


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.

 

 

 

...

البحث العلمي

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

...

البحث العلمي تسجيل

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

 

 

...

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: 23 June, 2022 - 9:47


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