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

Institut de la Macula y la Retina

Status: Unknown

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

Treatments: Dietary Supplement: Vitamins; Dietary Supplement: Postbotics and Vitamins

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05056025

2020/79-MIN-HUGC

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

postbiotics with vitamins

Experimental group

Description:

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

Treatment:

Dietary Supplement: Postbotics and Vitamins

vitamins

Placebo Comparator group

Description:

vitamins (AREDS formulation and recommended daily dose)

Treatment:

Dietary Supplement: Vitamins