Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
NCT ID: NCT00516464
Last Updated: 2007-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2007-08-31
2008-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
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Lucentis (ranibizumab)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Retina Associates, Kansas City
OTHER
Principal Investigators
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Gregory M Fox, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Associates, PA
Locations
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Retina Associates, PA
Shawnee Mission, Kansas, United States
Countries
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Facility Contacts
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References
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Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
Other Identifiers
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FVF4295
Identifier Type: -
Identifier Source: org_study_id