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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05056025
Other study ID # 2020/79-MIN-HUGC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2, 2020
Est. completion date January 2024

Study information

Verified date September 2021
Source Institut de la Macula y la Retina
Contact Jordi Mones, MD PhD
Phone +34 935 950 155
Email jmones@institutmacula.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date January 2024
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria: >4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy). 1 area of cRORA + 2 > areas of iRORA. < 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD. Exclusion Criteria: Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not ability to provide written informed consent. Not ability to return for all trial visits. if subject cannot attend all trial required visits. GA secondary to any condition other than specified. Any ocular condition in the study eye that would progress during the study that could affect central vision or otherwise be a confounding factor. Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B. Presence of intraocular inflammation (= trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria). Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year. Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition. Pregnant or nursing women. Additionally, women with childbearing potential must be using at least two effective contraception methods.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Postbotics and Vitamins
2 capsule 3 times a day, before meals
Vitamins
2 capsule 3 times a day, before meals

Locations

Country Name City State
Spain Institut de la Macula Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Institut de la Macula y la Retina Igen BioLab SLU

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microperimetry Median change difference in the % reduced threshold in microperimetry 12 months
Primary Color vision change Median change in red/green and yellow/blue color thresholds 12 months
Secondary Average Threshold microperimetry Mean change of Average Threshold microperimetry 12 months
Secondary Best corrected visual acuity (BCVA) Mean Change of Best corrected visual acuity (BCVA) 12 months
Secondary Low luminance visual acuity (LLVA) Mean Change of Low luminance visual acuity (LLVA) 12 months
Secondary Rod and cone sensitivity Mean change of Rod and cone sensitivity test 12 months
Secondary Advanced Vision and Optometric Test (AVOT) Mean change AVOT vision test 12 months
Secondary incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci Number of scans within the optical coherence tomography OCT cube as as per protocol (Spectralis OCT cube protocol: 20º x 20ª, 97b-scan, high-resolution, 62 microns between scans centered at the fovea) with features of iRORA2 conversion loci (change from baseline to 12 months of iRORA loci). 12 months
Secondary complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci Number of scans within the OCT cube as as per protocol with of features of cRORA (change from baseline to 12 months of cRORA loci). 12 months
Secondary Area of cumulative cRORA conversion Area of cumulative cRORA conversion as measured in mm2 by en face OCT projection scans of the OCT cube as as per protocol 12 months
Secondary Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion Number of scans within the OCT cube as as per protocol with HRD+RPE defects areas conversion (change from baseline to 12 months of HRD+RPE defects) 12 months
Secondary Change in outer nuclear layer (ONL) volume Change in outer nuclear layer (ONL) volume measured by the spectralis software after manually correction of the layer segmentation 12 months
Secondary Change of drusen > 100 microns height Change of number of drusen of > 100 microns height measured by OCT within the OCT cube as as per protocol 12 months
Secondary Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ) Change of number of subretinal drusenoid deposits (SDD) through ellipsoid zone within the OCT cube as as per protocol 12 months
Secondary Change of SDD ribbon Change of number SDD ribbon within the OCT cube as as per protocol 12 months
Secondary Conversion to choroidal neovascularization (CNV) Any conversion to any type of macular neovascularization (MNV) within the OCT cube as as per protocol 1 as per OCT features of leakage, and/or intrarretinal, subretinal or subRPE fluid, and/or presence of Subretinal hyperreflective material(SHRM) 12 months
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