Miscellaneous
An eye disease that blurs the sharp, central vision and usually occurs in older population.
What is AMD- Age-related macular degeneration?
Mean change in BCVA at Wk 54.
What is primary endpoint?
Each kit contains one IP vial and a “subject ID” label.
What is RGX-314 IP dose kit?
Portal that houses study documents and trainings and can be accessed by all site personnel as well as CRO and sponsor personnel.
What is Longboat?
This should occur within 10 business days of the first subject randomization, but prior to their surgery.
What is first monitoring visit?
What is 2 ( kits A and B)?
Masking status of photographers, study coordinators and CRAs.
What is partially masked?
Comparator used at screening.
What is Eylea(R) (Aflibercept)?
BCVA certification provider.
What is Clinical Edge?
The CRA and any sponsor representative must sign this document at each visit.
What is the Visit Sign-In Log?
Subject visit data should be entered into EDC within how many days of the visit?
What is 5?
Ranibizumab injection is administered at this visit.
What is screening?
Shipped and Stored at < -60°C.
What is IP?
Once lab samples are drawn, they are shipped to this lab facility.
What is Eurofins?
This platform is reviewed on a weekly basis by CRA to evaluate the status of each site and to address notifications. Used for risk based monitoring strategy.
What is DDM platform?
A microscope with a bright light used during an eye exam to see different structures at the front of the eye and inside the eye.
Aflibercept is administered at this visit.
What is randomization or Screening visit 3?
Shipped and Stored at 2-8°C.
What is Aflibercept & Ranibizumab?
When a site needs additional lab supplies, you would log into this portal to place the order.
What is Site Order Module (SOM)?
These must be reviewed at all visits.
What are Informed Consents (ICF)?
Central reading center for images.
What is MERIT?
Participants in the Control arm will be offered the chance to cross over and receive RGX314 at what point?
What is week 54?
RGX-314 IP was > -60°C for > 1 hour, or exceeded 0°C .
What is a temperature excursion?
The site used to register subject visits, order medication replacement and manage inventory.
What is 4G clinical?
This collection of documents and logs must be kept current and be made available for the CRA to review during each monitoring visit.
What is the Investigator Site File Binder (ISF)?
Fluid pressure inside the eye. Tonometry is the method used to measure this.
What is Intraocular Pressure (IOP)?
Starting at 6 Weeks post RGX-314 administration, participants can be evaluated for this.
What is Supplemental Anti-VEGF Injection?
Forms completed prior to IP administration.
What is a Chain of custody record?
When a patient needs to complete a questionnaire, you would have them log into this portal.
What is axiom ( Fusion )?
This log captures which site personnel are assigned to what tasks. It must be signed by the PI and must be reviewed by the CRA at each visit.
What is the Site Signature and Delegation Log?
Current treatments for Wet AMD.
What is laser surgery and Intravitreal Injections?
The surgical visit is how many weeks from screening visit 3?
What is 2 weeks?
Used to keep IP at appropriate temperature during transport.
What is U-Tek gel packs or dry ice?
If you needed help with patient travel and expense reimbursement, you would contact.
Who is ClinEdge?
Anything that is not done according to the protocol should be documented as this.
What is a protocol deviation?