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
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
  Purpose

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


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Drug: Lucentis (ranibizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Resource links provided by NLM:


Further study details as provided by Retina Associates, Kansas City:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516464

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
Investigators
Principal Investigator: Gregory M Fox, MD Retina Associates, PA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00516464     History of Changes
Other Study ID Numbers: FVF4295
Study First Received: August 14, 2007
Last Updated: August 14, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Associates, Kansas City:
Proliferative Diabetic Retinopathy
Vitrectomy
Ranibizumab

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014