NCT02353923

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

October 17, 2014

Last Update Submit

August 14, 2015

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • 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

    0 months, 3 months, 6 months

Secondary Outcomes (5)

  • Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)

    0 months, 3 months, 6 months

  • Change in Fluorescein Angiography

    0 months, 3 months, 6 months

  • Change in Microperimetry testing of macular function

    0 months, 3 months, 6 months

  • Change in Hemoglobin A1C blood levels

    0 months, 3 months, 6 months

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

    0 months, 3 months, 6 months

Study Arms (1)

OcuStem Supplementation

EXPERIMENTAL

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.

Dietary Supplement: OcuStem Supplementation

Interventions

OcuStem SupplementationDIETARY_SUPPLEMENT

2800 mg daily dosage of OcuStem, 2 capsules BID.

OcuStem Supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Shalesh Kaushal, MD

    Retina Specialty Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

February 3, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

August 18, 2015

Record last verified: 2015-08