Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

PHASE3CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Diabetic Macular Edema
Interventions
DRUG

ranibizumab

Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.

PROCEDURE

Laser

Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.

Trial Locations (20)

Unknown

Calgary Retina Consultants, Calgary

UBC - Eye Care Center, Vancouver

Retina Consultants of Victoria, Victoria

Memorial University Health Sciences Centre / Bense Eye Centre, St. John's

Victoria General Hospital, Department of Ophthalmology, Halifax

Ivey Eye Institute, London

Canadian Centre for Advanced Eye Therapeutics, Mississauga

The Ottawa Hospital - General Campus, Ottawa

St-Michael's Hospital - Dept of Ophthalmology, Toronto

Sunnybrook Health Sciences Centre, Toronto

Toronto Western Hospital, Toronto

Clinique ChirurgiVision, Drummondville

Hôpital Maisonneuve-Rosemont, Montreal

Hôpital Notre Dame (CHUM), Montreal

Royal Victoria Hospital, Montreal

Centre Oculaire de Québec, Québec

Dr.Michel Giunta Clinique Médicale, Sherbrooke

Saskatoon City Hospital / Spadina Clinic, Saskatoon

Institut de l'oeil des Laurentides, Québec

Memorial University Health Sciences Centre / Newfoundland Drive Medical Clinic, St. John's

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY