Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

Diabetic Retinopathy Clinical Trial

— DIVERSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366468
• Other study ID #: CRFB002DDE26
• Secondary ID: 2014-002854-37
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2015
• Est. completion date: June 8, 2017

Study information

• Verified date: January 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Vision Disorders

Intervention

Drug:
• ranibizumab 0.5 mg
intravitreal injection

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Ahaus
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Freiburg I. Br
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hösbach
Germany	Novartis Investigative Site	Kempten
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Tübingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wurzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)	BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity	Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Secondary	Number of Visits	Mean number of visits during the study	Baseline to Month 12
Secondary	Number of Injections	mean number of injections in the study eye during the study	Baseline to Month 12
Secondary	Number of Treatment Free Intervals	A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.	Baseline to Month 12
Secondary	Mean Change in Central Subfield Retinal Thickness (CSRT)	Evaluated by central reading center assessing OCT images	Baseline to Month 12
Secondary	Mean Change of Foveal Center Point Thickness	Evaluated by central reading center assessing OCT images	Baseline to Month 12
Secondary	Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale	Evaluated by central reading center scoring fundus photography	Baseline to Month 12