Supplemental Adjuvants for Intracellular Nutrition and Treatment
Information source: Mid-Atlantic Retina Consultations, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema
Intervention: Neutral pills with no medicinal effect (Drug); Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals (Dietary Supplement); Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Mid-Atlantic Retina Consultations, Inc. Official(s) and/or principal investigator(s):
Nabil M Jabbour, MD, FACS, Principal Investigator, Affiliation: M.A.R.C.
Overall contact:
Erica Cyphert, BA, Phone: 304-599-2733, Email: ericac@wvdsl.net
Summary
Nutritional supplements have an augmentative effect on the outcomes of standard treatment of
diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).
Clinical Details
Official title: The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: Degree of regression (Optical Coherence Tomography)Duration of regression (Optical Coherence Tomography) Visual change (ETDRS)
Secondary outcome: Effect on HbA1CEffect on Blood pressure Effect on serum uric acid
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical Diagnosis of NAMD
- Clinical Diagnosis of DME
Exclusion Criteria:
- Pregnant Women
- Known allergy to any component used in the treatment combinations
Locations and Contacts
Erica Cyphert, BA, Phone: 304-599-2733, Email: ericac@wvdsl.net
Mid-Atlantic Retina Consultations, Inc., Morgantown, West Virginia 26505, United States
Additional Information
Starting date: June 2009
Last updated: May 5, 2009
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