A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

Novartis Pharmaceuticals1 site in 1 country181 target enrollmentOctober 2013

ConditionsMacular Edema (ME)

InterventionsRanibizumab Sham control

DrugsRanibizumab

Overview

Phase: Phase 3
Intervention: Ranibizumab
Conditions: Macular Edema (ME)
Sponsor: Novartis Pharmaceuticals
Enrollment: 181
Locations: 1
Primary Endpoint: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

September 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
•BCVA must be between ≥ 24 and ≤ 83 letters;
•Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion Criteria

•Women of child-bearing potential,
•Active malignancies;
•History of stroke less than 6 months prior to screening;
•Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
•Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
•Any type of advanced, severe or unstable ocular disease or its reatment;
•ME with a high likelihood of spontaneous resolution.
•Other protocol-defined inclusion/exclusion criteria may apply.

Arms & Interventions

Ranibizumab

A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.

Intervention: Ranibizumab

Sham control

Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.

Intervention: Sham control

Outcomes

Primary Outcomes

Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye

Time Frame: Baseline, Month 2

BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.

Secondary Outcomes

Average Change From Baseline in BCVA(Baseline (BL), month 1 through month 6, month 1 through month 12)
Number of Participants Requiring Rescue Treatment at Month 1(Month 1)
Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline(Month 2, Month 6, Month 12)
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye(Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
Number of Participants With Re-treatments(Month 6, month 12)
Change From Baseline in BCVA in Study Eye up to Month 2(Baseline, Month 1, Month 2)
Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline(Month 2, Month 6, Month 12)
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
Number of Participants With Presence of Active Macular Edema (ME) Leakage(Month 2)
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss(Month 2, Month 6, Month 12)
Number of Primary Reasons for Decision to Treat by Investigator(12 months)
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters(Month 2, Month 6 , Month 12)
Number of Participants With Ranibizumab Treatments(Month 12)