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

Retina Associates, Kansas City

Status and phase

Unknown

Phase 3

Conditions

Proliferative Diabetic Retinopathy

Treatments

Drug: Lucentis (ranibizumab)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00516464

FVF4295

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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