scholarly journals THE HOMING TRIAL: A RETROSPECTIVE PILOT STUDY ON THE EFFICACY OF PERSONALIZED BIOIDENTICAL HORMONE, DIETARY SUPPLEMENT AND NUTRITION CARE PLANS FOR AGE-RELATED MACULAR DEGENERATION (AMD)

Author(s):  
George W. Rozakis ◽  
Brian A. Bakke

The objective of the Hormones, Oxidative stress, Methylation, Inflammation and Gene expression (HOMING) trial was to assess the efficacy of personalized bio identical hormone, dietary supplement and nutritional care plans on dry and wet Age-related Macular Degeneration (AMD) outcomes.  We evaluated 220 Age-related Macular Degeneration (AMD) patients that followed a personalized clinical care plan for up to 9 months.   The care plans consisted of bio identical hormones, dietary supplements and nutrition recommendations with the objective to improve lab and clinical measurements linked to oxidative stress, inflammation and gene expression.  Serum concentrations of CRP, HbA1c and homocysteine responded favorably to the HOMING protocol with full program compliance. Sixty percent (42/70) of wet AMD patients reported improvement in visual acuity and/or a reduction in the frequency of anti-VEGF injections during the study period.  Forty eight percent (44/92) of dry AMD patients reported improvement in visual acuity during the study period.  Nine percent (4/45) patients reported improvement in visual acuity in the dry AMD control group and no (0/13) wet AMD patients in the control group reported improvement.  Six percent (4/70) of wet AMD patients reported that their vision declined and/or that their F frequency increased during the study period.  Five percent (4/92) of dry AMD patients reported that their vision was worse.  Keywords:  Bio identical Hormones, Oxidative stress, Methylation, Inflammation, Gene Expression, Nutrition and AMD.

2014 ◽  
Vol 7 (4) ◽  
pp. 27-32
Author(s):  
Yuriy Sergeyevich Astakhov ◽  
Nikita Yur’yevich Dal’ ◽  
Natal’ya Viktorovna Chistyakova

Many patients with wet age-related macular degeneration (AMD) also have a cataract in the same eye. Because there is a theoretical risk of progression of the degenerative processes in the macular area after surgical lens removal, this raises some ethical, clinical and economical questions for ophthalmologists. The purpose of the study was to compare the course of wet AMD in eyes with incipient cataract and the course in eyes after surgical cataract removal. Materials and methods: 135 eyes with wet AMD, 48 eyes - treated group - were subjects to phacoemulsification during the study, 87 eyes - control group - with incipient cataract without indications for surgery. Regular visits every 1.5 months during 2 years of follow-up with visual acuity testing, central retinal thickness analysis by optical coherence tomography (OCT). Anti-VEGF injections were performed according to a PRN regimen. Results: there was no statistically significant difference in visual acuity, central retinal thickness, intravitreal injection frequency between both groups during the study period. Conclusions: No influence of phacoemulsification on the wet AMD course was found.


2013 ◽  
Vol 5 (2) ◽  
pp. 195-200 ◽  
Author(s):  
Sourav Ghosh ◽  
M Saha ◽  
D Das

Introduction: Age-related macular degeneration (AMD) related to adverse vascular changes is the most frequent cause of irreversible visual impairment in the elderly. Elevated plasma concentrations of serum homocysteine have been shown to increase the risk of vascular disease. Objective: To assess the relationship between plasma homocysteine level and age related macular degeneration. Materials and methods: A case control study was conducted in a tertiary eye care hospital with 32 diagnosed AMD patients. The patients were compared for plasma homocysteine levels with a control group of 32 patients without AMD. A 1.5 ml of fasting venous blood sample was obtained from each participant. Plasma homocysteine level was measured by high performance liquid chromatography. The main outcome measure was hyperhomocysteinemia, defined as a plasma homocysteine level above 15 μmol/l. Results: Hyperhomocysteinemia was found in 10 blood samples (83.3 %) of patients in the wet AMD group, in 16 (80 %) blood samples in the dry AMD group, and in 12 blood samples (37%) of controls. The mean ± SD homocysteine level in the AMD group was 16.86 ± 3.52 μmol/L, while in the non-AMD control group it was 14.53 ± 4.08 μmol/L. This difference was statistically significant (p-value = 0.0186). In the individual analysis, it was also found out that the homocysteine level differed significantly between cases and controls in only the wet variety of AMD. Conclusion: Hyperhomocysteinemia was significantly associated with the wet AMD variety but not with the dry AMD. Thus, homocysteine by oxidative stress and vascular dysfunction can be an important risk factor in the pathogenesis of AMD. Nepal J Ophthalmol 2013; 5(10): 195-200 DOI: http://dx.doi.org/10.3126/nepjoph.v5i2.8728


2014 ◽  
Vol 7 (4) ◽  
pp. 13-21
Author(s):  
Yuriy Sergeyevich Astakhov ◽  
Gassan Basharovich Shaar ◽  
Nikita Yur’yevich Dal’

Purpose. To study the effects of vitrectomy on the course of wet age-related macular degeneration (AMD). Materials and methods. 99 patients (99 eyes) with wet AMD associated with vitreo-macular adhesion or posterior hyaloid traction were included in the study. During the first 6 months, all patients received anti-VEGF treatment according to a PRN regimen. Then, they were divided into two groups: in 45 patients vitrectomy was performed and 54 patients did not receive surgical treatment. The follow-up period duration was one year. Results. At the beginning of the study, visual acuity was 0.27 ± 0.17 in the control group, and 0.17 ± 0.15 in the treatment group. Most prominent differences in visual acuity between the two groups were observed during the first 6 months (visual acuity in the treatment group before surgery was 0.12 ± 0.1) (p < 0.01 and p < 0.001), at the same time during the following 6 follow-up months, this difference decreased (p < 0.05 and p < 0.01). 1 year from the study start, visual acuity in the control group was 0.24 ± 0.17, and 0.17 ± 0.13 in the treatment one. Conclusions. Vitrectomy surgery in patients with wet AMD in association with vitreo-macular adhesion or posterior hyaloid traction does not exacerbate the disease course, stabilizes visual functions and improves the quality of life.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessandro Arrigo ◽  
Emanuela Aragona ◽  
Ottavia Battaglia ◽  
Andrea Saladino ◽  
Alessia Amato ◽  
...  

AbstractOuter retinal tubulations (ORT) are a relatively new finding characterizing outer retinal atrophy. The main aim of the present study was to describe ORT development in advanced age-related macular degeneration (AMD) and to assess its relationship with disease’s severity. Patients with advanced AMD characterized either by macular neovascularization or geographic atrophy, showing signs of outer retinal disruption or retinal pigment epithelium atrophy on structural optical coherence tomography (OCT) at the inclusion examination were prospectively recruited. All the patients underwent complete ophthalmologic evaluation, structural OCT scans and fundus autofluorescence imaging. The planned follow-up was of 3-years. Main outcome measures were ORT prevalence, mechanism of ORT formation, mean time needed for complete ORT formation, best-corrected visual acuity (BCVA), definitely decreased autofluorescence (DDAF) area, questionably decreased autofluorescence (QDAF) area, retinal layer thickness, foveal sparing, number of intravitreal injections. We also assessed the possible role of external limiting membrane (ELM) and Müller cells in ORT pathogenesis. Seventy eyes (70 patients) were included; 43 showed dry AMD evolving to geographic atrophy, while 27 displayed the features of wet AMD. Baseline BCVA was 0.5 ± 0.5 LogMAR, decreasing to 0.9 ± 0.5 LogMAR at the 3-year follow-up (p < 0.01). We detected completely formed ORT in 26/70 eyes (37%), subdivided as follows: 20 eyes (77%) wet AMD and 6 eyes (23%) dry AMD (p < 0.01). ORT took 18 ± 8 months (range 3–35 months) to develop fully. We described the steps leading to ORT development, characterized by progressive involvement of, and damage to the photoreceptors, the ELM and the RPE. Eyes displaying ORT were associated with a smaller QDAF area, less retinal layers damage and lower rate of foveal sparing than eyes free of ORT (p < 0.01). We also described pigment accumulations simulating ORT, which were detected in 16/70 eyes (23%), associated with a greater loss of foveal sparing, increased DDAF area and smaller QDAF area at the 3-year follow-up (p < 0.01). In conclusion, this study provided a description of the steps leading to ORT development in AMD. ELM and Müller cells showed a role in ORT pathogenesis. Furthermore, we described a subtype of pigment hypertrophy mimicking ORT, evaluating its clinical utility.


Biology ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 622
Author(s):  
Iswariyaraja Sridevi Gurubaran ◽  
Hanna Heloterä ◽  
Stephen Marry ◽  
Ali Koskela ◽  
Juha M. T. Hyttinen ◽  
...  

Aging-associated chronic oxidative stress and inflammation are known to be involved in various diseases, e.g., age-related macular degeneration (AMD). Previously, we reported the presence of dry AMD-like signs, such as elevated oxidative stress, dysfunctional mitophagy and the accumulation of detrimental oxidized materials in the retinal pigment epithelial (RPE) cells of nuclear factor erythroid 2-related factor 2, and a peroxisome proliferator-activated receptor gamma coactivator 1-alpha (NFE2L2/PGC1α) double knockout (dKO) mouse model. Here, we investigated the dynamics of inflammatory markers in one-year-old NFE2L2/PGC1α dKO mice. Immunohistochemical analysis revealed an increase in levels of Toll-like receptors 3 and 9, while those of NOD-like receptor 3 were decreased in NFE2L2/PGC1α dKO retinal specimens as compared to wild type animals. Further analysis showed a trend towards an increase in complement component C5a independent of component C3, observed to be tightly regulated by complement factor H. Interestingly, we found that thrombin, a serine protease enzyme, was involved in enhancing the terminal pathway producing C5a, independent of C3. We also detected an increase in primary acute phase C-reactive protein and receptor for advanced glycation end products in NFE2L2/PGC1α dKO retina. Our main data show C5 and thrombin upregulation together with decreased C3 levels in this dry AMD-like model. In general, the retina strives to mount an orchestrated inflammatory response while attempting to maintain tissue homeostasis and resolve inflammation.


2019 ◽  
Vol 20 (20) ◽  
pp. 5049 ◽  
Author(s):  
Ibuki ◽  
Shoda ◽  
Miwa ◽  
Ishida ◽  
Tsubota ◽  
...  

Background: Age-related macular degeneration (AMD) is the leading cause of blindness and can be classified into two types called atrophic AMD (dry AMD) and neovascular AMD (wet AMD). Dry AMD is characterized by cellular degeneration of the retinal pigment epithelium, choriocapillaris, and photoreceptors. Wet AMD is characterized by the invasion of abnormal vessels from the choroid. Although anti-vascular endothelial growth factor (VEGF) therapy has a potent therapeutic effect against the disease, there is a possibility of chorio-retinal atrophy and adverse systemic events due to long-term robust VEGF antagonism. We focused on hypoxia-inducible factor (HIF) regulation of VEGF transcription, and report the suppressive effects of HIF inhibition against ocular phenotypes in animal models. Many of the known HIF inhibitors are categorized as anti-cancer drugs, and their systemic side effects are cause for concern in clinical use. In this study, we explored food ingredients that have HIF inhibitory effects and verified their effects in an animal model of AMD. Methods: Food ingredients were screened using a luciferase assay. C57BL6/J mice were administered the Garcinia cambogia extract (Garcinia extract) and hydroxycitric acid (HCA). Choroidal neovascularization (CNV) was induced by laser irradiation. Results: Garcinia extract and HCA showed inhibitory effects on HIF in the luciferase assay. The laser CNV model mice showed significant reduction of CNV volume by administering Garcinia extract and HCA. Conclusions: Garcinia extract and HCA showed therapeutic effects in a murine AMD model.


2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Eva Rencová ◽  
Milan Bláha ◽  
Jan Studnička ◽  
Vladimír Bláha ◽  
Miriam Lánská ◽  
...  

Aim. To evaluate the long-term effect of rheohemapheresis (RHF) treatment of age-related macular degeneration (AMD) on photoreceptor IS/OS junction status.Methods. In our study, we followed 24 patients with dry AMD and drusenoid retinal pigment epithelium detachment (DPED) for a period of more than 2.5 years. Twelve patients (22 eyes) were treated by RHF and 12 controls (18 eyes) were randomized. The treated group underwent 8 RHF standardized procedures. We evaluated best-corrected visual acuity, IS/OS junction status (SD OCT), and macular function (multifocal electroretinography) at baseline and at 2.5-year follow-up.Results. RHF caused a decrease of whole-blood viscosity/plasma viscosity at about 15/12%. BCVA of treated patients increased insignificantlyP=0.187from median 74.0 letters (56.2 to 81.3 letters) to median 79.0 letters (57.3 to 83.4 letters), but it decreased significantly from 74.0 letters (25.2 to 82.6 letters) to 72.5 letters (23.4 to 83.1 letters) in the control groupP=0.041. The mfERG responses in the region of eccentricity between 1.8° and 7° were significantly higher in treated patientsP=0.04.Conclusions. RHF contributed to sparing of photoreceptor IS/OS junction integrity in the fovea, which is assumed to be a predictive factor for preservation of visual acuity.


2012 ◽  
Vol 93 (6) ◽  
pp. 994-996
Author(s):  
F R Saifullina ◽  
R Z Sharafieva ◽  
V I Pogorel’tsev ◽  
F M Fayzrahmanova ◽  
E A Abdulaeva

Aim. To assess the antioxidant capacity in patients with the «dry» form of age-related macular degeneration before and after combined treatment with polarized polychromatic non-coherent light and dynamic electromyostimulation. Methods. Two groups of patients with the «dry» form of age-related macular degeneration were examined. 40 patients (80 eyes) from the main group were treated using combined treatment and 39 patients (78 eyes) in the group of control who were treated conventionally. The integral blood antioxidant capacity was measured by galvanometry. Results. Blood antioxidant capacity in healthy subjects is 26.0 kC/l. In patients of the main group blood antioxidant capacity before the treatment was equal to 22.81±0.27 kC/l, compared to 22.17±0.20 kC/l in control group (total mean value 22.49±0.27 kC/l). There was a relevant elevation of the blood antioxidant capacity at the late stages after the treatment - up to 12 months, compared to only 2 months in the control group. Visual acuity in patients of the main group before the treatment was 0.87±0.02, after the treatment was finished - 0.96±0,01 (p 0.001), 2 months after the treatment - 0.95±0.01 (p 0.001), 6 months after the treatment - 0.96±0.01 (p 0.001), 12 months after the treatment - 0.95±0.01 (p 0.001). Visual acuity in patients of the control group before the treatment was 0.91±0.02, after the treatment was finished - 0.95±0.02 (p 0.05), 2 months after the treatment - 0.94±0.02 (p 0.05), 6 months after the treatment - 0.92±0.02 (p 0.05). 12 months after the treatment the visual acuity deteriorated compared to the treatment start and was measured as 0.89±0.02. Conclusion. There is a decrease of blood antioxidant capacity (22.49±0.27 kC/l) in patients with the «dry» form of age-related macular degeneration; a relevant increase of blood antioxidant capacity and visual acuity can be observed up to 12 months after the treatment with polarized polychromatic non-coherent light and dynamic electromyostimulation.


2019 ◽  
Vol 4 (1) ◽  
pp. e000109 ◽  
Author(s):  
Michel Weber ◽  
Laurent Velasque ◽  
Florence Coscas ◽  
Céline Faure ◽  
Isabelle Aubry ◽  
...  

Background/aimsTo monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.MethodsRAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT-AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.ResultsSafety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)µm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment-emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.ConclusionThis 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.Trial registration numberNCT02279537 Pre-results.


2019 ◽  
Vol 3 (6) ◽  
pp. 438-444
Author(s):  
Eliot R. Dow ◽  
Jennifer O. Adeghate ◽  
Peter G. Coombs ◽  
Mrinali Gupta Patel ◽  
Donald J. D’Amico ◽  
...  

Purpose: This article assesses anatomical and visual outcomes after intravitreal antivascular endothelial growth factor (anti-VEGF) treatment in fellow eyes with wet age-related macular degeneration (AMD). Methods: A retrospective chart review was conducted of 349 patients diagnosed with wet AMD between 2005 and 2017 at a single academic institution. Initial diagnosis of unilateral wet AMD and a minimum follow-up time of 1 year after diagnosis were required for inclusion. Individuals were excluded if the initial diagnosis of wet AMD was made at an outside institution, if they had received prior treatment at another institution, or if they had bilateral wet AMD at the time of inclusion. Best-corrected visual acuity, optical coherence tomography (OCT) parameters, and frequency and type of intravitreal anti-VEGF injections were recorded. MedCalc Statistical Software version 17.6 (MedCalc Software) and GraphPad Software (GraphPad Software, Inc) were used for statistical analysis. Results: Of the 349 patients with wet AMD, 192 were included in the study (55%). Of these, 47 (24.5%) developed wet AMD in the fellow eye. The average time to second-eye conversion was 2.6 years, with fellow-eye conversion more likely to occur after 2 years of unilateral disease. On average, patients received 2.16 fewer injections per year in the fellow eye compared with the initially diagnosed eye ( P = .03), and fellow eyes tended to have better OCT results after 12 months of treatment. In addition, compared with ranibizumab and bevacizumab, aflibercept injections appeared to improve visual acuity both in initially diagnosed and fellow eyes. Conclusions: Exudative AMD in the fellow eye has a decreased treatment burden and better visual outcomes compared with the initial eye, which may be attributed to more frequent surveillance and early diagnosis.


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