Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.

NCT05056025 | Unknown

• 1 other identifier: 2020/79-MIN-HUGC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AMD; Soft Drusen; Reticular Pseudodrusen; Drusen Stage Macular Degeneration; Drusen (Degenerative) of Macula, Bilateral

Keywords

postbiotic; vitamins; drusen; intermediate AMD

Outcome Measures

Primary Outcomes (2)

• Microperimetry

  Median change difference in the % reduced threshold in microperimetry

  12 months

• Color vision change

  Median change in red/green and yellow/blue color thresholds

  12 months

Secondary Outcomes (14)

• Average Threshold microperimetry

  12 months

• Best corrected visual acuity (BCVA)

  12 months

• Low luminance visual acuity (LLVA)

  12 months

• Rod and cone sensitivity

  12 months

• Advanced Vision and Optometric Test (AVOT)

  12 months

Study Arms (2)

postbiotics with vitamins

EXPERIMENTAL

postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose)

Dietary Supplement: Postbotics and Vitamins

vitamins

PLACEBO COMPARATOR

vitamins (AREDS formulation and recommended daily dose)

Dietary Supplement: Vitamins

Interventions

Postbotics and Vitamins DIETARY_SUPPLEMENT

2 capsule 3 times a day, before meals

postbiotics with vitamins

Vitamins DIETARY_SUPPLEMENT

2 capsule 3 times a day, before meals

vitamins

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• area of cRORA + 2 \> areas of iRORA. \< 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Institut de la Macula y la Retina: lead
• Igen BioLab SLU: collaborator

Study Sites (1)

Institut de la Macula

Barcelona, 08022, Spain

RECRUITING

MeSH Terms

Interventions

Vitamins

Intervention Hierarchy (Ancestors)

Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jordi Mones, MD, PhD

  Institut de la Macula

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Mones, MD PhD

CONTACT

+34 935 950 155; jmones@institutmacula.com

Miriam Garcia, OD, MSc

CONTACT

+34 935 950 155; mgarcia@institutmacula.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jordi Mones MD, PhD

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: September 24, 2021
• Study Start: December 2, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)