Clinical Trial Details

NCT ID: NCT00516464
Date Last Changed: August 14, 2007

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Lucentis (ranibizumab) for the treatment of Proliferative Diabetic Retinopathy

Research Study Title

Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Purpose

Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.

To Learn more

Recruitment Details

Phase
3
Gender
Both Male and Female
Age
21 and up
Overall Status
Recruiting
Lead Sponsor
Retina Associates, Kansas City
Duration
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 21 Years and up

Inclusion Criteria:

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

  • Age > 20 years

  • Best corrected visual acuity of 20/40 to 20/800 in the study eye

  • Very servere nonproliferative diabetic retinopathy (ETDRS level 53E) OR moderate proliferative diabetic retinopathy (ETDRS level 65)

  • Visual reduction attributable to diabetic vitreous hemorrhage or diabetic macular edema

  • Candidate for vitrectomy procedure

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.

  • Visual impairment attributable to causes other than diabetic macular edema or diabetic vitreous hemorrhage.

  • Use of intraocular or periocular corticosteroids within 6 months.

  • History of panretinal photocoagulation

  • History of macular laser photocoagulation

  • History of pars plana vitrectomy

  • Prior or concomitant treatment with ranibizumab, bevacizumab, or pegaptanib sodium, either as part of an investigational study or as an off-label medication.

  • Current treatment of a systemic infection

Site Locations (1)

Country State City Zip Facility and Contact
United States Kansas Shawnee Mission 66204 Retina Associates, PA
Lexie Manning
913-831-7400
lmanning@kcretina.com

Gregory M Fox, MD
Principal Investigator

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