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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Retina Associates, Kansas City.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Retina Associates, Kansas City
ClinicalTrials.gov Identifier:
NCT00516464
First received: August 14, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 14, 2007
August 14, 2007
August 2007
Not Provided
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
Drug: Lucentis (ranibizumab)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2008
Not Provided

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
Both
21 Years and older
No
United States
 
NCT00516464
FVF4295
No
Not Provided
Retina Associates, Kansas City
Genentech, Inc.
Principal Investigator: Gregory M Fox, MD Retina Associates, PA
Retina Associates, Kansas City
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP