Phase 3 N=345 Randomized Triple-blind Treatment

A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT00687804 ↗

Enrolled (actual)

345

Serious AEs

34.5%

Results posted

Apr 2011

Primary outcome: Primary: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 — 64.7; 63.4; 62.6; 70.8 Letters

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ranibizumab (Drug); Laser (Procedure); Sham laser (Procedure); Sham to ranibizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12	64.7; 63.4; 62.6; 70.8; 69.2; 63.4	—
PRIMARY Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study	56.6; 56.6; 52.5; 40.0; 2.4; 1.2	—
PRIMARY Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study	73.5; 73.5; 71.2; 73.3; 27.7; 30.1	—
SECONDARY Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12	43; 51; 17; 4; 5; 14	—
SECONDARY Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time	2.9; 3.1; 0.5; 4.4; 4.9; 0.4	—
SECONDARY Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye	427.1; 416.4; 412.4; 308.4; 288.2; 351.1	—
SECONDARY Core Study: Mean Change From Baseline in Patient-reported Visual Functioning	72.8; 74.1; 73.5; 77.8; 79.5; 74.1	—
SECONDARY Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies	66.3; 67.5; 64.4; 46.7; 2.4; 3.6	—
SECONDARY Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies	83.1; 81.9; 84.7; 73.3; 36.1; 37.3	—
SECONDARY Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36	0.1; -0.5; 3.7	—
SECONDARY Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36	8.0; 6.7; 6.0	—

Summary

CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema. CRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.

Eligibility Criteria

Inclusion Criteria

Visual acuity impairment
Diabetic macular edema in at least one eye
Type 1 or type 2 diabetes mellitus
Medication for the diabetes treatment must be stable for the last 3 months

Exclusion Criteria

Patients with uncontrolled systemic or ocular diseases
Laser photocoagulation in the study eye for the last 3 months
Any history of any intraocular surgery in the study eye within the past 3 months
Blood pressure > 160/100 mmHg

Extension Inclusion Criteria:

-Completion of the Core Study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00687804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.