An interventional study of Neutral pills with no medicinal effect and Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals in Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, sponsored by Mid-Atlantic Retina Consultations, Inc.. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by Mid-Atlantic Retina Consultations, Inc. · Not applicable, Interventional, and Treatment
Nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).
It has been shown that in chronic diseases, oxidative stress results from Nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial DNA. The potential for protecting the DNA and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for DME and NAMD with such supplements. The patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. Anatomic and visual outcomes, as well as side effects will be assessed and analyzed. If the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for DME, NAMD and perhaps other chronic illnesses.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 60 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Mid-Atlantic Retina Consultations, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Neutral pills with no medicinal effect
Dietary Supplement: Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals
Drug: Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline
Neutral pills with no medicinal effect
Inosine \[SR\] - 1\[500mg\] tablet bid Tocopherols \[200IU\], Tocotrienol \[10mg\], CoQ10 \[50mg\] - combination capsule bid Sustained Release Niacinamide - 1 \[750mg\] tablet bid Vitamin C - 1 \[1000mg\] sustained release tablet bid N-acetyl Cysteine - 1 \[600mg\] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid
Inosine \[SR\] - 1 \[500mg\] tablet bid Tocopherol \[200IU\], Tocotrienol \[10mg\], CoQ10 \[50mg\] combination capsule bid Sustained Release Niacinamide 1 \[750mg\] tablet bid Vitamin C 1 \[1000mg\] sustained release tablet bid N-acetyl Cysteine 1 \[600mg\] sustained release tablet qd Complete Multivitamin with all minerals - 1 tablet (sustained release) bid Minocycline 1 \[50mg\] tablet qd
Degree of regression (Optical Coherence Tomography)
Time frame: Monthly
Duration of regression (Optical Coherence Tomography)
Time frame: Monthly
Visual change (ETDRS)
Time frame: Monthly
Effect on HbA1C
Time frame: Monthly
Effect on Blood pressure
Time frame: Monthly
Effect on serum uric acid
Time frame: Monthly
This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Mid-Atlantic Retina Consultations, Inc.