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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00516464
Recruitment Status : Unknown
Verified August 2007 by Retina Associates, Kansas City.
Recruitment status was:  Recruiting
First Posted : August 15, 2007
Last Update Posted : August 15, 2007
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Retina Associates, Kansas City

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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516464


Locations
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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
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Principal Investigator: Gregory M Fox, MD Retina Associates, PA
More Information
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ClinicalTrials.gov Identifier: NCT00516464    
Other Study ID Numbers: FVF4295
First Posted: August 15, 2007    Key Record Dates
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:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
 Endocrine System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents