This trial is active, not recruiting.

Condition diabetic macular edema
Treatment ranibizumab
Phase phase 3
Target VEGF
Sponsor Novartis Pharmaceuticals
Start date September 2010
End date April 2013
Trial size 374 participants
Trial identifier NCT01171976, 2010-019795-74, CRFB002D2304


The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(Active Comparator)

Primary Outcomes

Mean average change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period.
time frame: 12 months

Secondary Outcomes

Evaluate whether the mean average change from baseline in BCVA obtained with either a 0.5 mg ranibizumab TE with adjunctive laser, or with 0.5 mg ranibizumab TE is non-inferior to 0.5 mg ranibizumab PRN
time frame: 24 months
Investigate within the TE dosing concepts the impact of laser treatment on the number of retreatments.
time frame: 24 Months
Investigate the efficacy of 0.5 mg ranibizumab TE with adjunctive laser, 0.5 mg ranibizumab TE and 0.5 mg ranibizumab PRN measured by the overall score assessed by VFQ-25 and EQ-5D.
time frame: 24 months
Time course of mean BCVA change from baseline to Month 12, and up to Month 24 obtained with either a 0.5 mg ranibizumab TE with adjunctive laser, or with 0.5 mg ranibizumab TE and with 0.5 mg ranibizumab PRN.
time frame: 24 months
To compare the changes in development of central subfield thickness (CSFT) of 0.5 mg ranibizumab TE with adjunctive laser, 0.5 mg ranibizumab TE and 0.5 mg ranibizumab PRN over time.
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patient - Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month. Ocular - Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye. - BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening. - Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment. Exclusion Criteria: Patient Compliance/ Administrative - Pregnant or nursing (lactating) women. Ocular medical history - Active intraocular inflammation (grade trace or above) in either eye at enrollment. - Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment. - History of uveitis in either eye at any time. - Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema. - Uncontrolled glaucoma in either eye at screening. Prior Ocular treatments - Panretinal laser photocoagulation in the study eye within 6 months prior to randomization. - Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization. - Treatment with anti-angiogenic drugs in either eye. Systemic conditions or treatments - History of stroke within 6 months prior to enrollment. - Renal failure requiring dialysis. - Untreated diabetes mellitus. - Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg. Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Novartis.