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Home » Clinical Trials » Diabetic Retinopathy

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Ranibizumab to evaluate Diabetic Retinopathy or Macular Edema

Research Study Title

Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema

Purpose

This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Retina Vitreous Associates of Florida

Duration

19 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study

  • Age > 18 years

  • Patient related considerations

  • Phakic or pseudophakic patients with a known history of diabetes will be eligible.

  • Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.

  • Disease related considerations:

  • Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.

  • Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40

  • Central foveal thickness on SD-OCT of > 300um

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

  • Participation in another simultaneous medical investigation or trial

  • Foveal ischemia on IVFA

  • Intraocular surgery less than 6 months ago

  • Epiretinal membrane of clinical significance

  • Prior vitrectomy

  • Uncontrolled glaucoma

  • Macular or peripheral laser within 90 Days from Day 0 injection

  • Intravitreal steroid injection within 90 days from Day 0 injection

  • Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

Site Locations (2)

Country State City Zip Facility and Contact
United States Florida Clearwater 33756 Retina Vitreous Associates of Florida
David Eichenbaum, MD
727-445-9110

David Eichenbaum, MD
Principal Investigator
United States Florida St. Petersburg 33711 Retina Vitreous Associates of Florida
David Eichenbaum, MD
727-323-0077

David Eichenbaum, MD
Principal Investigator

Contact

David Eichenbaum, MD
727-323-0077

NCT ID: NCT01476449

Date Last Changed: July 19, 2012

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