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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02366468
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

First listed
Feb 19, 2015
Start date
Feb 23, 2015
Status verified
Jan 2019
Primary completion
Jun 8, 2017
Completion
Jun 8, 2017

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Discretion of the investigator (DI)
    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.
  • Active Comparator: Pro re nata (PRN)
    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 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) [ Time Frame: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 ]

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