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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00516464
• Other study ID #: FVF4295
• Status: Recruiting
• Phase: Phase 3
• First received: August 14, 2007
• Last updated: August 14, 2007
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2007
• Source: Retina Associates, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Lucentis (ranibizumab)

Locations

Country	Name	City	State
United States	Retina Associates, PA	Shawnee Mission	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Retina Associates, Kansas City	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks.		6 months