Clinical Trial Basics
On this page you'll find information on the following:
Advances in medicine have saved millions of lives and improved the lives of many others.
These advances are made possible by the many people who participate in clinical trials.
Clinical trials help researchers determine if a new treatment, such as a new drug, is safe and effective.
Researchers also want to know if a new treatment is more effective and has fewer side effects than the standard treatment.
Clinical trials are conducted under the strict supervision of trial doctors and researchers.
These researchers need to follow a set of written instructions, described in a document called the protocol.
The US Food and Drug Administration (FDA) and other governmental agencies strictly regulate all clinical trials.
This means that the healthcare professionals involved in the trial follow rules established by the government.
These groups exist to protect the rights and well-being of people participating in clinical trials.
From time to time, the US Food and Drug Administration (FDA) inspects clinical trial study sites and checks the credentials of researchers and staff involved in trial research.
To test the safety and effectiveness of a drug, clinical trials must enroll a certain number of people.
The more people enrolled generally means more data can be collected during the trial.
Taking part in a clinical trial means you can help further the development of therapies that may improve the lives of people with your disease or condition.
Find a GATHER2 Clinical Trial location near you, and download the Doctor Discussion Guide to have a conversation with your doctor or clinical trial site staff about the risks and benefits of joining the GATHER2 Clinical Trial.
Clinical trials are split into four phases:
Phase 1 tests a new treatment on a small group of people.
Researchers are trying to determine the correct dosage of the treatment. And they want to look out for safety issues, such as side effects.
Phase 2 tests a treatment with a larger group of people.
Researchers want to know if the treatment has the potential to be effective for people who have a particular disease or condition.
Phase 3 typically involves a few hundred to a few thousand people.
A phase 3 trial looks to evaluate whether a treatment is safe and effective in a broader group of people.
The treatment may be approved following this phase if the US Food and Drug Administration (FDA) decides that the drug is safe and effective.
Typically, the FDA requires two phase 3 trials to be completed and submitted to show that the results are consistent. GATHER2 is the second phase 3 trial of Zimura® in geographic atrophy associated with age-related macular degeneration.
Phase 4 takes place after the treatment has been approved by the FDA.
The drug’s sponsor or manufacturer may need to continue to monitor the safety of the treatment in large, diverse groups of people.
ZIMURA® IS AN INVESTIGATIONAL PRODUCT AND HAS NOT BEEN APPROVED BY THE FDA. SAFETY AND EFFICACY OF ZIMURA® FOR AGE-RELATED MACULAR DEGENERATION AND GEOGRAPHIC ATROPHY HAVE NOT BEEN ESTABLISHED. PLEASE SPEAK TO YOUR DOCTOR ABOUT PARTICIPATING IN THIS TRIAL.
Zimura® (avacincaptad pegol) is a registered trademark of IVERIC bio, Inc.