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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: ranibizumab 0.5 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discretion of the investigator (DI)<br>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. | Drug: ranibizumab 0.5 mg<br>* intravitreal injection<br>* Other names: Lucentis;|
| Active Comparator: Pro re nata (PRN)<br>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 | Drug: ranibizumab 0.5 mg<br>* intravitreal injection<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic macular edema, Visual impairment