Overview

This trial is active, not recruiting.

Condition diabetic retinopathy
Treatments 0.5 mg ranibizumab
Phase phase 4
Sponsor Novartis Pharmaceuticals
Start date February 2015
End date June 2017
Trial size 135 participants
Trial identifier NCT02366468, 2014-002854-37, CRFB002DDE26

Summary

The purpose of this study is to demonstrate that the change of best corrected visual acuity (BCVA) is 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
0.5 mg ranibizumab
(Active Comparator)
0.5 mg ranibizumab

Primary Outcomes

Measure
Mean average change of BCVA
time frame: Baseline to Month 12

Secondary Outcomes

Measure
Number of visits
time frame: Baseline to Month 12
Number of injections
time frame: Baseline to Month 12
Number of treatment free intervals
time frame: Baseline to Month 12
Mean change in central subfield retinal thickness (CSRT)
time frame: Baseline to Month 12
Mean change of foveal center point thickness
time frame: Baseline to Month 12
Change in DRS retinopathy scale
time frame: Baseline to Month 12

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.