Clinical trial NCT00516464: Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Official title: Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proliferative Diabetic Retinopathy
Keywords: Proliferative Diabetic Retinopathy
Vitrectomy
Ranibizumab
Lead sponsor: Retina Associates, Kansas City
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shawnee Mission
country: United States
facility: Retina Associates, PA
state: Kansas
Study officials:
affiliation: Retina Associates, PA
name: Gregory M Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: