NICEVIVA
MONOGRAPH SPEC LATEST 2026

Zeolite

OTHER · Evidence Monograph

Zeolite is an evidence-graded other monograph evaluated across 24 peer-reviewed PubMed studies (4 meta-analyses, 2 systematic reviews, and 6 randomized controlled trials, encompassing n = 7,416 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 24 Studies
Meta-Analyses · Reviews 4 Meta · 2 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (1 Double-Blind)
Cumulative Participants n = 7,416
Reported Trial Dosages 4.12 g · 0.0714 g/day · 2 mg
Trial Duration Range 4 weeks · 16 weeks · 8 weeks
Reading Time ~12 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 24 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (4.12 g · 0.0714 g/day · 2 mg) over a structured 4 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
With Breakfast or Lunch
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary other clinical efficacy (24 PubMed studies)
Quantitative biomarker & outcome analysis (12 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 1 double-blind)
Systematic review & meta-analysis synthesis (4 meta-analyses · 2 reviews)
01

What Is Zeolite & Why Does Form Matter?

Zeolite is classified under OTHER and has been investigated across 24 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (4.12 g, 0.0714 g/day, 2 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Zeolite frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Zeolite acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Zeolite an overall evidence rating of GRADE High (4.0 / 4.0) based on 24 PubMed studies: 4 meta-analyses, 2 systematic reviews, and 6 randomized controlled trials (1 double-blind, n = 7,416 total participants).

Representative peer-reviewed findings include: • PMID:36736058 (2023) — "A meta-analysis of the effects of clay mineral supplementation on alkaline phosphatase, broiler health, and performance." (Aluminosilicate was superior in improving the mucosal immunity status of broiler chickens.) • PMID:36607319 (2023) — "Effect of clay supplementation on growth performance of broiler chickens: a systematic review and meta-analysis." (In conclusion, an appropriate addition level is a prerequisite for effective clay application.) • PMID:41407269 (2026) — "Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial." (CONCLUSIONS: Dosing of ACP 2 mg, either EM or EOM, continued to reduce GA growth versus sham therapy over 2 years with no new safety signals compared with year 1.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 4.12 g · 0.0714 g/day · 2 mg · 6.0 mg over 4 weeks · 16 weeks · 8 weeks · 12 weeks. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Zeolite, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (4.12 g · 0.0714 g/day · 2 mg) and re-evaluate efficacy after 4 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (24 Studies) · 12 Quantitative Analyses

01
META-ANALYSIS Poultry science (2023) PMID: 36736058 ↗
A meta-analysis of the effects of clay mineral supplementation on alkaline phosphatase, broiler health, and performance.
Clinical Trial Synthesis 2023 Meta-Analysis published in Poultry science; statistical significance reported at p = 0.01. Key conclusion: Aluminosilicate was superior in improving the mucosal immunity status of broiler chickens.
View Original PubMed Abstract ↓

The crucial constraint in the broiler production sector is feed efficiency; many feed additives have been widely employed to increase broiler growth. Nonetheless, some of these substances exacerbate health and animal-based food product safety concerns. This meta-analysis examines the effect of clay minerals on alkaline phosphatase (ALP), broiler health, and performance. Metadata was constructed from 369 data items that were harvested from 86 studies. The addition of clay minerals was set as a fixed effect and the difference between experiments was established as a random effect. The metadata were fitted using a linear mixed model. Due to the presence of clay minerals, growth performance as assessed by body weight (BW), average daily gain (ADG), and performance efficiency index (PEI) increased significantly (P < 0.01). In the total period, the increases of BW, ADG, and PEI were 4.12 g, 0.0714 g/d, and 0.648, respectively, per unit of clay minerals added. Clay minerals did not affect blood serum parameters (e.g., ALP and calcium). The IgA and IgM concentrations in the jejunum and ileum were significantly greater (P < 0.01) in the starter phase. Among clay minerals, broilers fed diets with aluminosilicate, halloysite, kaolin, and zeolite consistently exhibited higher (P < 0.05) BW, ADG, PEI, and lower feed conversion ratio (P < 0.05) in the finisher phase. Aluminosilicate was the only clay that increased (P < 0.05) secretory IgA concentration in both jejunum and ileum. In conclusion, clay minerals could be used as a growth promoter, especially during the finisher phase, without adversely affecting feed intake, liver function, and mineral metabolism in broiler chickens. Aluminosilicate was superior in improving the mucosal immunity status of broiler chickens.

02
META-ANALYSIS British poultry science (2023) PMID: 36607319 ↗
Effect of clay supplementation on growth performance of broiler chickens: a systematic review and meta-analysis.
Clinical Trial Synthesis 2023 Meta-Analysis published in British poultry science; statistical significance reported at p = 0.001. Key conclusion: In conclusion, an appropriate addition level is a prerequisite for effective clay application.
View Original PubMed Abstract ↓

1. This review assessed the effect of dietary clay supplementation as a drug and toxin adsorbent on broiler growth performance as a meta-analysis.2. A total of 33 eligible studies were included in the present study after identification and evaluation from online databases. Standardised mean differences (SMD) with corresponding 95% confidence intervals were computed with a fixed-effects model.3. The results indicated that clay supplementation significantly improved broiler daily gain (P < 0.001) and feed conversion ratio (P < 0.001), but did not affect feed intake (P = 0.954). Results of subgroup analysis showed that zeolite clay had the most stable medium improvement effect on FCR, while kaolin had a large effect. In addition, male broilers and Cobb or Ross broilers were more sensitive to the addition of clay, and the best supplemental levels, in general, were 10 g/kg to 30 g/kg.4. Meta-regression analysis showed that clay supplemental level and sex of broilers may be important factors in the effect of clay on ADG and FCR of broilers, respectively. The sensitivity analysis showed high stability of the results and no significant publication bias was found with funnel plot analysis and Egger's or Begg's test (P > 0.05).5. In conclusion, an appropriate addition level is a prerequisite for effective clay application. Kaolin and zeolite clays seem to be more suitable for enhancing broiler growth performance, and the value of clay is amplified in specific broiler breeds.

03
CLINICAL STUDY Ophthalmology (2026) PMID: 41407269 ↗
Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Ophthalmology involving n = 225 participants; statistical significance reported at p = 0.0165. Key conclusion: CONCLUSIONS: Dosing of ACP 2 mg, either EM or EOM, continued to reduce GA growth versus sham therapy over 2 years with no new safety signals compared with year 1.
View Original PubMed Abstract ↓

PURPOSE: Avacincaptad pegol (ACP) is a pegylated RNA aptamer that inhibits complement C5. The efficacy and safety of ACP 2 mg was investigated in GATHER2, with positive year 1 results published. Herein, 2-year results are reported. DESIGN: Phase 3, randomized, sham-controlled study (ClinicalTrials.gov identifier, NCT04435366). PARTICIPANTS: Patients with non-center point-involving geographic atrophy (GA). METHODS: Eligible patients were randomized 1:1 to receive monthly ACP 2 mg (n = 225) or sham (n = 222) for 1 year. At month 12, patients who received ACP 2 mg were randomized again 1:1 to dosing every month (EM; n = 96) or every other month (EOM; n = 93) with ACP 2 mg. Patients who had received monthly sham continued with sham (n = 203). MAIN OUTCOME MEASURES: The safety and efficacy of ACP versus sham administration over 2 years and the effect of ACP EM or EOM dosing in year 2. RESULTS: Overall, 175 and 184 patients in the ACP and sham group completed the study at year 2, respectively. At 2 years, treatment with ACP demonstrated a continued reduction in GA growth (slope) with both ACP EM and EOM versus sham. From baseline to year 2, the mean rate of GA area growth was 4.46 mm2 (standard error [SE], 0.25 mm2) with ACP EM and 5.18 mm2 (SE, 0.17 mm2) with sham, a difference in growth of 0.724 mm2 (95% confidence interval [CI], 0.133-1.315 mm2; P = 0.0165), representing a 14% difference. From baseline to year 2, the mean rate of GA area growth was 4.20 mm2 (SE, 0.25 mm2) with ACP EOM, a difference in growth of 0.976 mm2 (95% CI, 0.377-1.575 mm2; nominal P = 0.0015) versus sham, representing a 19% difference. The incidence of choroidal neovascularization (study eye) was 11.6% with ACP (all treated) versus 9.0% with sham over 2 years. No events of retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation occurred over 2 years. CONCLUSIONS: Dosing of ACP 2 mg, either EM or EOM, continued to reduce GA growth versus sham therapy over 2 years with no new safety signals compared with year 1. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

04
CLINICAL STUDY Ophthalmology. Retina (2025) PMID: 40107501 ↗
Faricimab Treat-and-Extend Dosing for Macular Edema Due to Retinal Vein Occlusion: 72-Week Results from the BALATON and COMINO Trials.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Ophthalmology. Retina involving n = 553 participants. Key conclusion: RESULTS: Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72.
View Original PubMed Abstract ↓

PURPOSE: To assess the efficacy, durability, and safety of dual angiopoietin-2/VEGF inhibition with faricimab dosed per a modified treat-and-extend-based regimen in patients with retinal vein occlusion. DESIGN: Single-arm treatment period after a randomized, double-masked, active comparator-controlled period in the phase III BALATON/COMINO (NCT04740905/NCT04740931) trials. PARTICIPANTS: Patients with treatment-naïve foveal center-involved macular edema due to branch (BALATON; N = 553) or central/hemiretinal (COMINO; N = 729) retinal vein occlusion. METHODS: Patients randomized to faricimab 6.0 mg every 4 weeks (Q4W) or aflibercept 2.0 mg Q4W up to week 20 received faricimab 6.0 mg dosed per a modified treat-and-extend-based regimen from week 24 to 72. The dosing frequency was adjusted from Q4W to Q16W based on changes in central subfield thickness (CST) and best-corrected visual acuity. MAIN OUTCOME MEASURES: Change from baseline through week 72 in best-corrected visual acuity and CST; durability and safety through week 72. RESULTS: Visual acuity gains and CST reductions achieved at week 24 were maintained through week 72. Adjusted mean best-corrected visual acuity (95.03% confidence interval [CI]) changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were +18.1 letters (16.9-19.4) and +18.8 letters (17.5-20.0), respectively, in BALATON and +16.9 letters (15.2-18.6) and +17.1 letters (15.4-18.8), respectively, in COMINO. Adjusted mean (95.03% CI) CST changes from baseline averaged over weeks 64, 68, and 72 in the prior faricimab Q4W and prior aflibercept Q4W arms were -310.9 μm (-315.6 to -306.3) and -307.0 μm (-311.7 to -302.3), respectively, in BALATON and -465.9 μm (-472.5 to -459.3) and -460.6 μm (-467.2 to -453.9), respectively, in COMINO. In the prior faricimab Q4W and prior aflibercept Q4W arms, 64.1% and 56.9% of patients from BALATON and 45.5% and 50.1% from COMINO, respectively, were on ≥Q12W dosing at week 68. Faricimab continued to be well tolerated from weeks 24 to 72; the safety profile was consistent with that established for diabetic macular edema and neovascular age-related macular deg

05
CLINICAL STUDY Ophthalmology (2024) PMID: 38382813 ↗
TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Ophthalmology involving n = 555 participants (MD -0.2). Key conclusion: At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing.
View Original PubMed Abstract ↓

PURPOSE: To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. DESIGN: TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. PARTICIPANTS: Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. METHODS: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. MAIN OUTCOME MEASURES: Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. RESULTS: Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [95% confidence interval (CI), +2.1 to +5.4] and +3.3 letters [95% CI, +1.7 to +4.9], respectively; mean difference, +0.4 letters [95% CI, -1.9 to +2.8]) and LUCERNE (adjusted mean change, +5.0 letters [95% CI, +3.4 to +6.6] and +5.2 letters [95% CI, +3.6 to +6.8], respectively; mean difference, -0.2 letters [95% CI, -2.4 to +2.1]). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectivel

06
RANDOMIZED TRIAL (RCT) Ophthalmology (2024) PMID: 38158159 ↗
Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Ophthalmology involving n = 940 participants. Key conclusion: Mean CST reductions were greater (YOSEMITE/RHINE we
View Original PubMed Abstract ↓

PURPOSE: To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME). DESIGN: Randomized, double-masked, noninferiority phase 3 trials. PARTICIPANTS: Adults with visual acuity loss (best-corrected visual acuity [BCVA] of 25-73 letters) due to center-involving DME. METHODS: Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg every 8 weeks. The T&E up to every-16-week dosing regimen was based on central subfield thickness (CST) and BCVA change. MAIN OUTCOME MEASURES: Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100. RESULTS: In YOSEMITE and RHINE (n = 940 and 951, respectively), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92, 96, and 100 average) with faricimab every 8 weeks (YOSEMITE and RHINE, +10.7 letters and +10.9 letters, respectively) or T&E (+10.7 letters and +10.1 letters, respectively) were comparable with aflibercept every 8 weeks (+11.4 letters and +9.4 letters, respectively). The median number of study drug injections was lower with faricimab T&E (YOSEMITE and RHINE, 10 and 11 injections, respectively) versus faricimab every 8 weeks (15 injections) and aflibercept every 8 weeks (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was improved further during year 2, with > 60% of patients receiving every-16-week dosing and approximately 80% receiving every-12-week or longer dosing at week 96. Almost 80% of patients who achieved every-16-week dosing at week 52 maintained every-16-week dosing without an interval reduction through week 96. Mean CST reductions were greater (YOSEMITE/RHINE we

07
RANDOMIZED TRIAL (RCT) Lancet (London, England) (2023) PMID: 37865470 ↗
Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Lancet (London, England) involving n = 1,258 participants. Key conclusion: FINDINGS: Between Aug 30, 2018, and July 3, 2020, 1258 patie
View Original PubMed Abstract ↓

BACKGROUND: Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy. METHODS: OAKS and DERBY were two 24-month, multicentre, randomised, double-masked, sham-controlled, phase 3 studies, in which patients aged 60 years and older with geographic atrophy secondary to age-related macular degeneration were enrolled at 110 clinical sites and 122 clinical sites worldwide, respectively. Patients were randomly assigned (2:2:1:1) by central web-based randomisation system to intravitreal 15 mg per 0·1 mL pegcetacoplan monthly or every other month, or sham monthly or every other month using stratified permuted block randomisation (stratified by geographic atrophy lesion area at screening, history or presence of active choroidal neovascularisation in the eye not under assessment, and block size of six). Study site staff, patients, reading centre personnel, evaluating physicians, and the funder were masked to group assignment. Sham groups were pooled for the analyses. The primary endpoint was the change from baseline to month 12 in the total area of geographic atrophy lesions in the study eye based on fundus autofluorescence imaging, in the modified intention-to-treat population (ie, all patients who received one or more injections of pegcetacoplan or sham and had a baseline and at least one post-baseline value of lesion area). Key secondary endpoints (measured at 24 months) were change in monocular maximum reading speed of the study eye, change from baseline in mean functional reading independence index score, change from baseline in normal luminance best-corrected visual acuity score, and change from baseline in the mean threshold sensitivity of all points in the study eye by mesopic microperimetry (OAKS only). Safety analyses included patients who were randomly assigned and received at least one injection of pegcetacoplan or sham. The now completed studies are registered with ClinicalTrials.gov, NCT03525613 (OAKS) and NCT03525600 (DERBY). FINDINGS: Between Aug 30, 2018, and July 3, 2020, 1258 patie

08
CLINICAL STUDY Japanese journal of ophthalmology (2023) PMID: 36897413 ↗
Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in Japanese patients with diabetic macular edema: 1-year results from the Japan subgroup of the phase 3 YOSEMITE trial.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Japanese journal of ophthalmology involving n = 1,891 participants. Key conclusion: CONCLUSION: Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME.
View Original PubMed Abstract ↓

PURPOSE: To evaluate efficacy, durability, and safety of faricimab in Japanese patients with diabetic macular edema (DME). STUDY DESIGN: Subgroup analysis of 2 global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 trials (YOSEMITE, NCT03622580; RHINE, NCT03622593). METHODS: Patients with DME were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W), faricimab 6.0 mg per personalized treatment interval (PTI), or aflibercept 2.0 mg Q8W through week 100. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at 1 year, averaged over weeks 48, 52, and 56. This is the first time 1-year outcomes between Japanese patients (only enrolled into YOSEMITE) and the pooled YOSEMITE/RHINE cohort (N = 1891) have been compared. RESULTS: The YOSEMITE Japan subgroup included 60 patients randomized to faricimab Q8W (n = 21), faricimab PTI (n = 19), or aflibercept Q8W (n = 20). Consistent with global results, the adjusted mean (95.04% confidence interval) BCVA change at 1 year in the Japan subgroup was comparable with faricimab Q8W (+11.1 [7.6-14.6] letters), faricimab PTI (+8.1 [4.4-11.7] letters), and aflibercept Q8W (+6.9 [3.3-10.5] letters). At week 52, 13 (72%) patients in the faricimab PTI arm achieved ≥ Q12W dosing, including 7 (39%) patients receiving Q16W dosing. Anatomic improvements with faricimab were generally consistent between the Japan subgroup and pooled YOSEMITE/RHINE cohort. Faricimab was well tolerated; no new or unexpected safety signals were identified. CONCLUSION: Consistent with global results, faricimab up to Q16W offered durable vision gains and improved anatomic and disease-specific outcomes among Japanese patients with DME. © 2023. Japanese Ophthalmological Society.

09
RANDOMIZED TRIAL (RCT) World journal of gastroenterology (2022) PMID: 36569277 ↗
Safety and efficacy of purified clinoptilolite-tuff treatment in patients with irritable bowel syndrome with diarrhea: Randomized controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in World journal of gastroenterology involving n = 30 participants; statistical significance reported at p = 0.0353. Key conclusion: Stool microbiome studies showed a minor increase in diversity in the G-PUR® group but not in the placebo group.
View Original PubMed Abstract ↓

BACKGROUND: Irritable bowel syndrome (IBS) is a highly prevalent gastrointestinal disorder with poor response to treatment. IBS with predominant diarrhea (IBS-D) is accompanied by abdominal pain as well as high stool frequency and urgency. Purified clinoptilolite-tuff (PCT), which is approved by the Food and Drug Administration for use as a dietary supplement with the brand name G-PUR®, has previously shown therapeutic potential in other indications based on its physical adsorption capacity. AIM: To assess whether symptoms of IBS-D can be ameliorated by oral treatment with PCT. METHODS: In this randomized, placebo-controlled, double-blind pilot study, 30 patients with IBS-D diagnosis based on Rome IV criteria were enrolled. Following a 4-wk run-in phase, 14 patients were randomized to receive a 12-wk treatment with G-PUR® (2 g three times daily), and 16 patients received placebo. The relief from IBS-D symptoms as measured by the proportion of responders according to the Subject's Global Assessment (SGA) of Relief was assessed as the primary outcome. For the secondary outcomes, validated IBS-D associated symptom questionnaires, exploratory biomarkers and microbiome data were collected. RESULTS: The proportions of SGA of Relief responders after 12 wk were comparable in both groups, namely 21% in the G-PUR® group and 25% in the placebo group. After 4 wk of treatment, 36% of patients in the G-PUR® group vs 0% in the placebo group reported complete or considerable relief. An improvement in daily abdominal pain was noted in 94% vs 83% (P = 0.0353), and the median number of days with diarrhea per week decreased by 2.4 d vs 0.3 d in the G-PUR® and placebo groups, respectively. Positive trends were observed for 50% of responders in the Bristol Stool Form Scale. Positive trends were also noted for combined abdominal pain and stool consistency response and the Perceived Stress Questionnaire score. Only 64% in the G-PUR® group compared to 86% in the placebo group required rescue medication intake during the study. Stool microbiome studies showed a minor increase in diversity in the G-PUR® group but not in the placebo group. No PCT-related serious adverse events were reporte

10
RANDOMIZED TRIAL (RCT) Lancet (London, England) (2022) PMID: 35085503 ↗
Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Lancet (London, England) involving n = 1,532 participants. Key conclusion: PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits.
View Original PubMed Abstract ↓

BACKGROUND: To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody. METHODS: YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593). FINDINGS: 3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], d

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