Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
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|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
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy||Drug: Lucentis (ranibizumab)||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|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|
- 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 ]
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
|United States, Kansas|
|Retina Associates, PA||Recruiting|
|Shawnee Mission, Kansas, United States, 66204|
|Contact: Lexie Manning 913-831-7400 firstname.lastname@example.org|
|Principal Investigator: Gregory M Fox, MD|
|Principal Investigator:||Gregory M Fox, MD||Retina Associates, PA|