Clinical trial NCT02366468: Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Official title: A 12-months, Randomized, VA-assessor Blinded, Multicenter, Controlled Phase IV Trial to Investigate Noninferiority of Two Treatment Algorithms (Discretion of the Investigator vs. Pro re Nata) of 0.5 mg Ranibizumab in Patients With Visual Impairment Due to Diabetic Macula Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Retinopathy
Keywords: Diabetic macular edema
Visual impairment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).


Eligibility criteria: Inclusion Criteria:

* Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0%
* Patients with visual impairment due to DME in at least one eye
* BCVA ≥ 24 and ≤ 78 letters in the study eye

Exclusion Criteria:

* Active intraocular inflammation
* Any active infection in either eye at the
* Structural damage within 0.5 disc diameter of the center of the macula in the study eye
* Uncontrolled glaucoma in either eye at screening

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)
timeFrame: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary outcomes:
measure: Number of Visits
timeFrame: Baseline to Month 12
measure: Number of Injections
timeFrame: Baseline to Month 12
measure: Number of Treatment Free Intervals
timeFrame: Baseline to Month 12
measure: Mean Change in Central Subfield Retinal Thickness (CSRT)
timeFrame: Baseline to Month 12
measure: Mean Change of Foveal Center Point Thickness
timeFrame: Baseline to Month 12
measure: Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative Site
city: Freiburg I. Br
country: Germany
facility: Novartis Investigative Site
city: Gottingen
country: Germany
facility: Novartis Investigative Site
city: Greifswald
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hösbach
country: Germany
facility: Novartis Investigative Site
city: Kempten
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wurzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: