Clinical trial NCT05056025: Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.
Official title: A PILOT STUDY TO EVALUATE THE PROGRESSION OF THE DISEASE AND RESPONSE TO SUPPLEMENTATION WITH POSTBIOTICS IGEN-0222 IN PATIENTS WITH MACULAR DEGENERATION
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AMD
Soft Drusen
Reticular Pseudodrusen
Drusen Stage Macular Degeneration
Drusen (Degenerative) of Macula, Bilateral
Keywords: postbiotic
vitamins
drusen
intermediate AMD
Lead sponsor: Institut de la Macula y la Retina
Sponsor class: OTHER
Collaborators: name: Igen BioLab SLU
First posted: 2021-09-24
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Microperimetry
timeFrame: 12 months
measure: Color vision change
timeFrame: 12 months
Secondary outcomes:
measure: Average Threshold microperimetry
timeFrame: 12 months
measure: Best corrected visual acuity (BCVA)
timeFrame: 12 months
measure: Low luminance visual acuity (LLVA)
timeFrame: 12 months
measure: Rod and cone sensitivity
timeFrame: 12 months
measure: Advanced Vision and Optometric Test (AVOT)
timeFrame: 12 months
measure: incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci
timeFrame: 12 months
measure: complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci
timeFrame: 12 months
measure: Area of cumulative cRORA conversion
timeFrame: 12 months
measure: Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion
timeFrame: 12 months
measure: Change in outer nuclear layer (ONL) volume
timeFrame: 12 months
measure: Change of drusen > 100 microns height
timeFrame: 12 months
measure: Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)
timeFrame: 12 months
measure: Change of SDD ribbon
timeFrame: 12 months
measure: Conversion to choroidal neovascularization (CNV)
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de la Macula
Study officials:
affiliation: Institut de la Macula
name: Jordi Mones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: