Clinical trial NCT02353923: OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
Official title: OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Aidan Products LLC
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether supplementation with OcuStem, a nutritional supplement, will reduce the progression of mild to moderate diabetic retinopathy.

Detailed description: This research study is designed to evaluate the effects of a nutritional supplement, OcuStem, on mild to moderate nonproliferative diabetic retinopathy. In this condition blood vessels in the back of the eye, an area termed the retina, are deteriorating. OcuStem contains ingredients that have previously been demonstrated in clinical trials to stimulate a type of cell, called "endothelial progenitor cells" to increase in circulation. Animal studies have shown that increasing endothelial progenitor cell numbers inhibits progression of diabetic retinopathy. The hypothesis of the study is that a 6 month course of OcuStem will reduce progression of mild to moderate diabetic retinopathy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* One or both study eyes per subject may be enrolled.
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Any one of the following will be considered to be sufficient evidence that diabetes is present:

  1. Current regular use of insulin for the treatment of diabetes
  2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  3. Documented diabetes by ADA and/or WHO criteria.
* The study eye must meet the following:

  1. Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam.
  2. No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness \<250 microns(or spectral domain OCT equivalent).
  3. Visual acuity light perception or better.

Exclusion Criteria:

* A current ocular condition that, in the opinion of the investigator, visual acuity might be affected now and/or may need to be treated (e.g., DME, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition (cataract ), epiretinal membrane or vitro-macular traction) or during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
* A history of a major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery including cataract removal anticipated within the next 4 months following enrollment.
* Pregnant Women

Primary outcomes:
measure: Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing
timeFrame: 0 months, 3 months, 6 months
Secondary outcomes:
measure: Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)
timeFrame: 0 months, 3 months, 6 months
measure: Change in Fluorescein Angiography
timeFrame: 0 months, 3 months, 6 months
measure: Change in Microperimetry testing of macular function
timeFrame: 0 months, 3 months, 6 months
measure: Change in Hemoglobin A1C blood levels
timeFrame: 0 months, 3 months, 6 months
measure: Change in Blood levels of circulating endothelial progenitor cells (EPC)
timeFrame: 0 months, 3 months, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Retina Specialty Institute
name: Shalesh Kaushal, MD
role: PRINCIPAL_INVESTIGATOR
References: