Supplemental Adjuvants for Intracellular Nutrition and Treatment

Not Applicable

• Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
• Interventions: 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

• Registration Number: NCT00893724
• Lead Sponsor: Mid-Atlantic Retina Consultations, Inc.

Brief 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).

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.

Study Timeline

• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Study Start: 2009-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20
• Primary Completion: 2011-08
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical Diagnosis of NAMD
• Clinical Diagnosis of DME

Exclusion Criteria

• Pregnant Women
• Known allergy to any component used in the treatment combinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P (Placebo)	Neutral pills with no medicinal effect	-
S (Supplement)	Inosine; Tocopherols, Tocotrienol, CoQ10 combination capsule; Niacinamide SR; Viatmin C; N-acetyl Cysteine; Complete Multivitamin with all minerals	-
SM (Supplement with Minocycline)	Inosine; Tocopherol, Tocotrienol, CoQ10 combination capsule; Niacinamide; Vitamin C; N-acetyl Cysteine; Complete Multivitamin with all minerals; Minocycline	-

Primary Outcome Measures

Name	Time	Method
Degree of regression (Optical Coherence Tomography)	Monthly
Duration of regression (Optical Coherence Tomography)	Monthly
Visual change (ETDRS)	Monthly

Secondary Outcome Measures

Name	Time	Method
Effect on HbA1C	Monthly
Effect on Blood pressure	Monthly
Effect on serum uric acid	Monthly

Trial Locations

Locations (1)

Mid-Atlantic Retina Consultations, Inc.; 🇺🇸 Morgantown, West Virginia, United States