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

Phase 4

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: ranibizumab 0.5 mg

• Registration Number: NCT02366468
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Study Start: 2015-02-23
• Primary Completion: 2017-06-08
• Study Completion: 2017-06-08
• Results First Submitted: 2018-06-05
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-01
• Last Update Submitted: 2019-01-01
• Results First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discretion of the investigator (DI)	ranibizumab 0.5 mg	ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.
Pro re nata (PRN)	ranibizumab 0.5 mg	ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred

Primary Outcome Measures

Name	Time	Method
Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)	Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 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

Secondary Outcome Measures

Name	Time	Method
Number of Injections	Baseline to Month 12	mean number of injections in the study eye during the study
Mean Change in Central Subfield Retinal Thickness (CSRT)	Baseline to Month 12	Evaluated by central reading center assessing OCT images
Mean Change of Foveal Center Point Thickness	Baseline to Month 12	Evaluated by central reading center assessing OCT images
Number of Treatment Free Intervals	Baseline to Month 12	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.
Number of Visits	Baseline to Month 12	Mean number of visits during the study
Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale	Baseline to Month 12	Evaluated by central reading center scoring fundus photography

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wurzburg, Germany