Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2007 by Retina Associates, Kansas City.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Genentech

Information provided by:

Retina Associates, Kansas City

ClinicalTrials.gov Identifier:

NCT00516464

First received: August 14, 2007

Last updated: NA

Last verified: August 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 14, 2007

Last Updated Date

August 14, 2007

Start Date ^ICMJE

August 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks. [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

This is an open-label, Phase I/II study of multiple doses of intravitreally administered ranibizumab in patients with severe NPDR and PDR prior to, during, and after vitrectomy therapy.

40 subjects will be enrolled and randomized 3:1 to ranibizumab or vitrectomy alone. 30 consented, enrolled subjects will receive 3 intravitreal injections of 0.5 mg ranibizumab administered 1-3 weeks pre-procedure, intraoperatively, and 1 month post-vitrectomy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Proliferative Diabetic Retinopathy

Intervention ^ICMJE

Drug: Lucentis (ranibizumab)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00516464

Other Study ID Numbers ^ICMJE

FVF4295

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Retina Associates, Kansas City

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Principal Investigator:

Gregory M Fox, MD

Retina Associates, PA

Information Provided By

Retina Associates, Kansas City

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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