Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema - Full Text View

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	Phase III

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Edema

ChemIDplus related topics:

Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, 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:

Change from baseline in visual acuity from baseline in 12-month treatment period, treatment with ranibizumab (10 mg/ml)

Secondary Outcome Measures:

12 months treatment with ranibizumab (10 mg/ml) and laser photocoagulation as standard of care
Change in retinal thickness from baseline
Change in Visual acuity from Baseline
Quality of Life assessment at baseline, last visit
Safety assessment (Incidence of ocular and non-ocular adverse events at each visit)

Estimated Enrollment:	315
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental	Drug: Ranibizumab
2: Active Comparator	Drug: Ranibizumab
3	Drug: Ranibizumab

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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
	Eye Clinic (B4A), Westmead Hospital	Recruiting
	Westmead, Australia
	Contact: Paul Mitchell, MD 61-2845-7960 paul_mitchell@wmi.usyd.edu.au

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Professor Paul Mitchell	Eye Clinic (B4A) Westmead Hospital, Australia

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRFB002D2301, EUDRACT: 2007-004877-24
First Received:	May 27, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00687804
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

Diabetic

macula

edema

ranibizumab

Study placed in the following topic categories:

Sensation Disorders

Signs and Symptoms

Macular Edema

Vision Disorders

Eye Diseases

Retinal Degeneration

Macular Degeneration

Neurologic Manifestations

Edema

Retinal Diseases

Vision, Low

Retinal degeneration

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00687804