Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema (RESTORE)

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Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema (RESTORE)
This study is currently recruiting participants.
Verified by Novartis, November 2008
Sponsored by: Novartis

Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00687804

Purpose
This study is 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.

Condition Intervention Phase
Diabetic Macular Edema
Drug: Ranibizumab
Procedure: Ranibizumab
Drug: Ranibizumab + Laser
Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Edema Infectious Mononucleosis
Drug Information available for: Ranibizumab
U.S. FDA Resources
Study Type:Interventional
Study Design:Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:A Randomized, Double-Masked, Multicenter, Laser-Controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-Therapy in Patients With Visual Impairment Due to Diabetic Macular Edema

Further study details as provided by Novartis:

Primary Outcome Measures:
Mean change from baseline in Best-corrected Visual acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Number of patients with BCVA and in the number of patients with improvement in BCVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Time course of BCVA changes on ranibizumab (0.5 mg) adjunctive and mono-therapy relative to laser treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Change on retinal thickness and other anatomical changes relative to laser treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Evaluation of the patient-reported outcomes (PROs) relative to laser treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Safety evaluation of intravitreal injections of ranibizumab (0.5 mg) in patients with DME overall and relative to laser treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:315
Study Start Date:May 2008
Estimated Primary Completion Date:December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Ranibizumab
0.5 mg ranibizumab + sham laser
2: Active Comparator Procedure: Ranibizumab
sham injection+ laser photocoagulation
3: Experimental Drug: Ranibizumab + Laser
0.5 mg ranibizumab + laser photocoagulation

Eligibility
Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687804

Contacts
Contact: Novartis Pharmaceuticals 41-61-324-1111

Locations
Australia
Novartis Investigative Site Recruiting
Melbourne, Australia
Contact: Novartis +41-61-324-1111
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium
Contact: Novartis +41-61-324-1111
Canada
Novartis Investigative Site Not yet recruiting
Ontario, Canada
Contact: Novartis +1 862-778-8300
France
Novartis Investigative Site Recruiting
Paris, France
Contact: Novartis +41-61-324-1111
Germany
Novartis Investigative Site Recruiting
Düsseldorf, Germany
Contact: Novartis +41-61-324-1111
Greece
Novartis Investigative Site Recruiting
Athens, Greece
Contact: Novartis +41-61-324-1111
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary
Contact: Novartis +41-61-324-1111
Italy
Novartis Investigative Site Recruiting
Firenze, Italy
Contact: Novartis +41-61-324-1111
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands
Contact: Novartis +41-61-324-1111
Spain
Novartis Investigative Site Recruiting
Barcelona, Spain
Contact: Novartis +41-61-324-1111
Switzerland
Novartis Investigational Site Recruiting
Zurich, Switzerland
Contact: Novartis +41-61-324-1111
Turkey
Novartis Investigative Site Recruiting
Ankara, Turkey
Contact: Novartis +41-61-324-1111
United Kingdom
Novartis Investigative Site Not yet recruiting
Upton, United Kingdom
Contact: Novartis +41-61-324-1111

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party:Novartis ( External Affairs )
Study ID Numbers:CRFB002D2301, EUDRACT: 2007-004877-24
First Received:May 27, 2008
Last Updated:November 6, 2008
ClinicalTrials.gov Identifier:NCT00687804 [history]
Health Authority:Switzerland: Swissmedic; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Paul-Ehrlich-Institut; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
DME
Diabetic
macula
edema
ranibizumab

Study placed in the following topic categories:
Sensation Disorders
Vision Disorders
Eye Diseases
Edema
Macular Degeneration
Retinal Degeneration
Vision, Low
Macular Edema
Signs and Symptoms
Infectious Mononucleosis
Neurologic Manifestations
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Nervous System Diseases