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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Proliferative Diabetic Retinopathy	Drug: Lucentis (ranibizumab)	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Study Start Date :	August 2007
Estimated Study Completion Date :	August 2008

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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, Inc.

Investigators

Principal Investigator:	Gregory M Fox, MD	Retina Associates, PA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00516464 History of Changes
Other Study ID Numbers:	FVF4295
First Posted:	August 15, 2007
Last Update Posted:	August 15, 2007
Last Verified:	August 2007

Keywords provided by Retina Associates, Kansas City:

Proliferative Diabetic Retinopathy; Vitrectomy; Ranibizumab

Additional relevant MeSH terms:

Retinal Diseases; Diabetic Retinopathy; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases	Ranibizumab; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents