Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01171976
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Study Details

The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

Key Dates

First listed
Jul 29, 2010
Start date
Sep 30, 2010
Status verified
Sep 2014
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

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

Arms

  • Experimental: TE Ranibizumab 0.5 mg and Laser
    On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.
  • Experimental: TE Ranibizumab 0.5 mg alone
    Patients received ranibizumab intravitreal injection therapy only.
  • Active Comparator: PRN Ranibizumab 0.5 mg
    Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Primary Outcome Measure

Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12 [ Time Frame: Baseline to Month 12 ]

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