What are the different phases of a clinical trial for inherited retinal diseases?
There are four different phases in a clinical trial. The time from a phase one to a phase four trial can take many years, and it is common for your treatment to be “masked” in that time (so you may not know whether you have the real treatment or are on a placebo).
- These are the earliest trials in the life of a new drug, device or treatment.
- They are usually small trials, recruiting up to 30 patients.
- Phase 1 trials are conducted to determine the safety of a potential treatment.
- People recruited to Phase 1 trials often have advanced eye disease.
- These trials must be completed first as safety is the most important issue to resolve before wider testing is undertaken.
- This type of trial tests the potential new treatment in a larger number of volunteers to learn more about how the body responds to the treatment, the optimal dose of the treatment and how the treatment affects a certain eye condition.
- If the results of Phase 2 trials show that a new treatment may be as good as or better than an existing treatment, Phase 3 will begin.
- In inherited retinal diseases, because the number of possible trial participants is small, Phases 1 and 2 are sometimes run together in a Phase 1/2 trial.