An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

Novartis Pharmaceuticals1 site in 1 country7 target enrollmentJanuary 2011

ConditionsDiabetic Macular Edema

InterventionsRanibizumab

DrugsRanibizumab

Overview

Phase: Phase 4
Intervention: Ranibizumab
Conditions: Diabetic Macular Edema
Sponsor: Novartis Pharmaceuticals
Enrollment: 7
Locations: 1
Primary Endpoint: Change in Best Corrected Visual Acuity(BCVA)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

November 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Visual impairment due to focal or diffuse macular edema with center involvement
•Diabetes type 1 or 2, HbA1c \< 12.0%
•CRT = or \> 250 μm

Exclusion Criteria

•Active inflammation or infection
•Uncontrolled glaucoma
•Iris neovascularization, active proliferative retinopathy or vitreomacular traction
•Prior laser photocoagulation according to defined timelines
•History of stroke, uncontrolled hypertension
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

Ranibizumab

Intervention: Ranibizumab

Outcomes

Primary Outcomes

Change in Best Corrected Visual Acuity(BCVA)

Time Frame: from month 0 (baseline) to month 12

Secondary Outcomes

change in central retinal thickness (CRT)(from month 0 to month 12)
the number of injections needed(12 months)
the number of patients with improvement in BCVA from baseline(12 months)
the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84(12 months)