Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This is an open-label, Phase I/II study of intravitreally administered ranibizumab either
0.5-mg and/or 2.0-mg in subjects with clinical, angiographic, and ocular coherence tomography
(OCT) evidence of diabetic retinopathy with associated diabetic macular edema following
bevacizumab therapy. Thirty patients will be enrolled in this study.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5
mg ranibizumab administered every 30 days (±7 days) for 3 injections during the mandatory
treatment phase (Day 0, Month 1, and Month 2).
Subjects with complete resolution of diabetic macular edema after 3 intravitreal injections
of 0.5 mg ranibizumab will be treated as necessary with 0.5 mg ranibizumab to treat recurrent
macular edema for an additional 9 months (12 months from Day 0). The intent is to administer
additional ranibizumab treatment if there is evidence of disease activity documented on OCT
(e.g., intra-retinal fluid, subretinal fluid and/or cystic changes).
Subjects with residual diabetic macular edema following 3 intravitreal injections of 0.5 mg
ranibizumab will be receive 3 intravitreal injections of 2.0 mg ranibizumab administered
every 30 days (±7 days) for 3 injections at the Month 3, Month 4, and Month 5 study visits.
Beginning at the Month 6 study visit, subjects with complete resolution of diabetic macular
edema following 3 intravitreal injections of 2.0 mg ranibizumab will treated as necessary
with 2.0 mg ranibizumab injections only to treat recurrent macular edema for an additional 6
months (12 months from Day 0).
Subjects with residual diabetic macular edema following 3 consecutive intravitreal injections
of 2.0 mg ranibizumab will be treated as necessary with 2.0 mg ranibizumab to treat
persistent or recurrent macular edema for an additional 6 months (12 months from Day 0).
Focal photocoagulation or intravitreal triamcinolone may be administered at the physician's
discretion as an adjunct to ranibizumab injections beginning at Month 6 through Month 12 of
the study.
All subjects will make monthly visits for 12 months for evaluation of safety and efficacy.
All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety
visit one week (±2 days) after the first injection. At subsequent visits, the subject will
have a safety evaluation at the monthly scheduled follow-up visit prior to any intravitreal
injection. Subjects will be contacted by the site personnel 1-2 days after each injection to
elicit reports of decreased vision or pain or unusual new ocular symptoms in the study eye.