NCT02326259

Brief Summary

The investigators are doing this research for two reasons. The first is to see how the retina (back of your eye) changes when your blood sugar is treated with medication for the first time. This will help us better understand the progression of a condition known as Diabetic Retinopathy. The second reason is to provide diabetic blood samples, which will possibly help identify biomarkers for diabetic retinopathy. Biomarkers are things that indicate the presence of a specific condition, and indicate a higher likelihood of developing that condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

7 years

First QC Date

December 22, 2014

Last Update Submit

August 11, 2022

Conditions

Diabetic Retinopathy

Keywords

Diabetic RetinopathyDisease Progression

Outcome Measures

Primary Outcomes (1)

  • Progression of diabetic retinopathy

    90 days

Interventions

Initiation of treatment of diabetesOTHER

Treatment of diabetes according to the standard of care.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being seen in the endocrinology clinic at Temple University Hospital.

You may qualify if:

  • Presenting to the endocrinology clinic with a hemoglobin A1c of greater than 12.

You may not qualify if:

  • Patients with other ocular or systemic conditions, including macular degeneration, uveitis, glaucoma, and autoimmune conditions (Rheumatoid Arthritis, Lupus, and other similar conditions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyDisease Progression

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William J Foster, MD, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

  • Ajay D Rao, MD, MMSc, FACP

    Temple University

    PRINCIPAL INVESTIGATOR

  • Raul A DeLa Cadena, MD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 29, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

US(1)