B1181003 Clinical Study of RN6G (PF-04382923)

• Research type

  Research Study

• Full title

  A PHASE 2 MULTI-CENTER, RANDOMIZED, DOUBLE-MASKED, PLACEBO CONTROLLED, MULTI-DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RN6G (PF 04382923) IN SUBJECTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION

• IRAS ID

  112564

• Contact name

  Andrew Lotery

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017

• Eudract number

  2012-000823-42

• ISRCTN Number

  n/a

• Research summary

  This clinical study has been designed for individuals who have geographic atrophy (GA) secondary to advanced dry age-related macular degeneration (AMD). AMD is a progressive disease that results in loss of central vision. The dry form of AMD accounts for 90% of the approximately 15 million sufferers of AMD. Currently, there are no approved drug treatments for dry AMD or its complications, such as GA. The purpose of this research study is to evaluate the effectiveness of the study drug, named RN6G (PF-04382923), in subjects with GA. RN6G is in a class of drugs called monoclonal antibodies. Antibodies are proteins that are generated by the white blood cells that are circulating in your body all the time. Antibodies circulate in the blood and attach to foreign proteins that are also called antigens, in order to destroy or get rid of them. For example, when you are exposed to a virus, your body will produce antibodies to help rid your body of the virus. Monoclonal antibodies are laboratory produced substances which are produced under very clean and sterile conditions, that can locate and bind to specific molecules such as Amyloid-beta (or AÇ?), a fat-protein found in the yellow deposits (also known as drusen) in the eyes of people with AMD. Drusen may be involved in causing the vision loss seen in people with AMD. AÇ? is also found in very large amounts in the brains of people with Alzheimer??s disease, a disease that affects memory, and your ability to think. There will be about 276 people enrolled in this study which is being conducted at about 100 different research sites, in about 6 countries. Participants will be in this study for about 18 to 19 months and will need to visit the research site at least 19 times during the study.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0502

• Date of REC Opinion

  16 Nov 2012

• REC opinion

  Further Information Favourable Opinion