Ranibizumab for persistent diabetic macular edema after bevacizumab (ROTATE)

Institution: Southeast Retina Center

Author/principal investigator: Dennis M. Marcus, MD

Abstract/statement of the trial’s goals

This is an open-label phase 1/2 study of intravitreally administered 0.3 mg Lucentis (ranibizumab, Genentech) in patients with persistent diabetic macular edema (DME) after recent and frequent Avastin (bevacizumab, Genentech), defined as at least two bevacizumab intravitreal injections within 2 months prior to enrollment and at least six bevacizumab injections within 9 months of enrollment.

ClinicalTrials.gov identifier: NCT01845844

Study population: 30

Inclusion criteria

Age older than 18 years.
Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Type 1/2 diabetes mellitus.
Central-involved DME in study eye (central subfield thickness ≥ 275 µm on Heidelberg Spectralis spectral-domain optical coherence tomography with evidence of intraretinal or subretinal fluid or cysts).
Definite retinal thickening due to DME involving the center of the macula.
Media clarity, pupillary dilation and individual cooperation for adequate fundus photography and fluorescein angiography.
Visual acuity score in study eye ≤ 80 and ≥ 20 (approximate Snellen equivalent: 20/25 to 20/400).
History of at least six intravitreal bevacizumab injections within the past 9 months and two intravitreal bevacizumab injections within the past 2 months.
No history of an anti-VEGF treatment for DME in the past 3 weeks.
No other treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.
No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next 6 months following randomization.

Exclusion criteria

Pregnancy or lactation.
Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated.
Participation in another medical investigation or trial within 30 days of randomization.
Known allergy to ranibizumab.
Acute cardiovascular event requiring hospitalization within the past 3 months.
Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study.
Macular edema is considered to be due to a cause other than DME.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema.
History of intravitreal anti-VEGF agent other than bevacizumab within 9 months prior to randomization.
History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization.
YAG capsulotomy performed within 1 month prior to randomization.
External ocular infection including conjunctivitis, significant blepharitis, etc.

Enrollment status: Currently recruiting participants.