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| Name | Class |
|---|---|
| Igen BioLab SLU | INDUSTRY |
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A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy secondary to age-related macular degeneration, myopia, or angioid streaks.
A pilot study to evaluate the safety and efficacy of oral therapy with Postbiotics in patients with geographic atrophy (GA) secondary to age-related macular degeneration, myopia or angioid streaks.
The study's main objective is to evaluate if oral postbiotic therapy will induce epigenetic factors that would impact the progression of the GA, and it will compare the rate of growth of GA from the Baseline to 12 months, to the rate shown during the 12 months before Baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with GA secondary to AMD, myopia or angioid streaks | Experimental | postbiotics (IGENH35.3A) with vitamins (AREDS formulation and recommended daily dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| postbiotics (IGENH35.3A) | Dietary Supplement | postbiotics to induce microbiota epigenetic factors |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of growth of geographic atrophy (GA) as per SQRT (square roor transformation) of area of GA measured in FAF, (fundus autofluorescence) | rate of growth of GA as per SQRT of FAF area compared to rate of growth of the previous year | 12 months |
| safety and tolerability | safety and tolerability of daily dosing of oral postbiotics assessed by number of patients with clinically significant changes of a combination of ocular and/or non-ocular adverse events | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
- history of choroidal neovascularization in the study eye
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Monés, MD, PhD | Institut de la Mà cula | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de la MÃ cula | Barcelona | 08022 | Spain |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| vitamins (AREDS formulation and recommended daily dose) | Dietary Supplement | vitamins (AREDS to prevent AMD progression |
|
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |