Various factors including feedback from ethics boards and regulators will impact our progress. If dates are provided, they are estimates only.
- Determine appropriate funding sources (FFB, CRFC, CIHR)
- Receive local ethics approval from the University of Alberta research ethics board
- Order and receive diagnostic equipment
- Sign a collaboration agreement with international colleagues so that we can use the vector they have developed
- Complete the Clinical Trial Application (CTA) to Health Canada. This application requires collaboration among the many individuals involved in this trial, including our international colleagues. The CTA requires administrative and clinical information about the trial as well as the quality and safety data for the vector that will be used. Here is an overview of the CTA requirements.
- Meet with Health Canada to discuss the final content of the CTA and to give Health Canada advanced notice of what to expect
- Finalize the CTA and submit it to Health Canada for approval. Health Canada will respond within 30 days of receiving the application
- Develop recruitment criteria for the clinical trial. The criteria for inclusion in the clinical trial will be determined and clearly communicated before recruitment begins. Potential participants will be screened to determine if they meet the inclusion criteria. Selection will depend partly on the preliminary results of study participants who have undergone gene therapy in Oxford, England. In addition, it will be limited to males, over age 18 and with a confirmed diagnosis of choroideremia. Baseline visual exams will also help determine participant eligibility.
- Receive Health Canada approval/No Objection Letter
- Address questions raised by Health Canada in the No Objection Letter
- Assessing potential participants (no one is guaranteed study enrollment)
- Start recruiting for the clinical trial
- Start the clinical trial with a small number of participants