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

This study is currently recruiting participants.

Verified by Retina Associates, Kansas City, August 2007

Sponsors and Collaborators:	Retina Associates, Kansas City Genentech
Information provided by:	Retina Associates, Kansas City
ClinicalTrials.gov Identifier:	NCT00516464

Purpose

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

Condition	Intervention	Phase
Proliferative Diabetic Retinopathy	Drug: Lucentis (ranibizumab)	Phase III

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Further study details as provided by Retina Associates, Kansas City:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516464

Locations

United States, Kansas
Retina Associates, PA	Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Lexie Manning 913-831-7400 lmanning@kcretina.com
Principal Investigator: Gregory M Fox, MD

Sponsors and Collaborators

Retina Associates, Kansas City

Genentech

Investigators

Principal Investigator:

Gregory M Fox, MD

Retina Associates, PA

More Information

Study ID Numbers:	FVF4295
Study First Received:	August 14, 2007
Last Updated:	August 14, 2007
ClinicalTrials.gov Identifier:	NCT00516464
Health Authority:	United States: Food and Drug Administration

Keywords provided by Retina Associates, Kansas City:

Proliferative Diabetic Retinopathy
Vitrectomy
Ranibizumab

Study placed in the following topic categories:

Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009