A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus (RISE)

Sponsor
Genentech, Inc.
Study ID
NCT00473330
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus
  • Macular Edema

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Sterile solution for intravitreal injection.
  • Sham injection — DRUG

Study Details

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473382 (Protocol ID FVF4168g). The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.

Key Dates

First listed
May 15, 2007
Start date
Jun 30, 2007
Status verified
Mar 2017
Primary completion
Nov 30, 2010
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: Ranibizumab 0.3 mg
    Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months.
  • Experimental: Ranibizumab 0.5 mg
    Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months.
  • Sham Comparator: Sham injection/ranibizumab 0.5 mg
    Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months.

Primary Outcome Measure

Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 [ Time Frame: Baseline to Month 24 ]

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