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OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy

Primary Purpose

Diabetic Retinopathy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

OcuStem Supplementation

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OcuStem Supplementation

Arm Description

Twice daily supplementation with OcuStem. Subjects will take 2 capsules in the morning and 2 capsules at night for a total of 2800 mg/day of active ingredients.

Outcomes

Primary Outcome Measures

Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing

Electronic-ETDRS visual acuity testing at 3 meters using the Electronic Visual Acuity Tester (including protocol refraction) in each eye

Secondary Outcome Measures

Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)

Optical Coherence Tomography OCT on the study eye or eyes. This is to determine if there is any development of diabetic macular edema

Change in Fluorescein Angiography

Fluorescein Angiography on the study eye or eyes. This is to determine if there is any subtle evidence of diabetic changes including microaneurisms or mild macular edema.

Change in Microperimetry testing of macular function

Microperimetry testing of macular function. This non-invasive test measures retinal sensitivity to various intensities of light in a defined region of the macula

Change in Hemoglobin A1C blood levels

This is a well-established standard marker for diabetic control

Change in Blood levels of circulating endothelial progenitor cells (EPC)

Blood levels of circulating endothelial progenitor cells (EPC) as determined by CD34 levels

Full Information

NCT ID

NCT02353923

First Posted

October 17, 2014

Last Updated

August 14, 2015

Sponsor

Aidan Products LLC

1. Study Identification

Unique Protocol Identification Number

NCT02353923

Brief Title

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

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aidan Products LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OcuStem Supplementation

Arm Type

Experimental

Arm Description

Twice daily supplementation with OcuStem. Subjects will take 2 capsules in the morning and 2 capsules at night for a total of 2800 mg/day of active ingredients.

Intervention Type

Dietary Supplement

Intervention Name(s)

OcuStem Supplementation

Intervention Description

2800 mg daily dosage of OcuStem, 2 capsules BID.

Primary Outcome Measure Information:

Title

Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing

Description

Electronic-ETDRS visual acuity testing at 3 meters using the Electronic Visual Acuity Tester (including protocol refraction) in each eye

Time Frame

0 months, 3 months, 6 months

Secondary Outcome Measure Information:

Title

Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)

Description

Optical Coherence Tomography OCT on the study eye or eyes. This is to determine if there is any development of diabetic macular edema

Time Frame

0 months, 3 months, 6 months

Title

Change in Fluorescein Angiography

Description

Fluorescein Angiography on the study eye or eyes. This is to determine if there is any subtle evidence of diabetic changes including microaneurisms or mild macular edema.

Time Frame

0 months, 3 months, 6 months

Title

Change in Microperimetry testing of macular function

Description

Microperimetry testing of macular function. This non-invasive test measures retinal sensitivity to various intensities of light in a defined region of the macula

Time Frame

0 months, 3 months, 6 months

Title

Change in Hemoglobin A1C blood levels

Description

This is a well-established standard marker for diabetic control

Time Frame

0 months, 3 months, 6 months

Title

Change in Blood levels of circulating endothelial progenitor cells (EPC)

Description

Blood levels of circulating endothelial progenitor cells (EPC) as determined by CD34 levels

Time Frame

0 months, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by ADA and/or WHO criteria. The study eye must meet the following: Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam. No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness <250 microns(or spectral domain OCT equivalent). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shalesh Kaushal, MD

Organizational Affiliation

Retina Specialty Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy

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