Gyrate Atrophy Ocular and Systemic Study
Conditions: Gyrate Atrophy, Gyrata of Choroid and Retina; Atrophy, Ornithine-δ-aminotransferase, OAT, Chorioretinal Degeneration
Sponsor: Jaeb Center for Health Research

Jaeb Center for Health Research
15310 Amberly Drive, Suite 350
Tampa, FL 33647
Tel: (813) 975-8690
Fax: (813) 975-8761
jkennedy@jaeb.org
Tuesday, January 9, 2024
RE: Gyrate Atrophy Ocular and Systemic Study (GYROS)
Dear Investigator,
This Protocol Administrative Change Letter (PACL) is to notify you of the following administrative
changes and clarifications to the GYROS Protocol; Version 1.2, dated 28-Nov-22. The edit described 
below is to clarify inconsistencies in the text of the protocol and provide an administrative change 
that does not impact the safety of subjects, the scope of the trial, or the scientific quality of the study, 
and therefore does not qualify as an amendment.
This PACL identifies the following discrepancies:
Page 13, Protocol Overview/Synopsis, states Participants who enroll into the study cohort 
will return to the clinic within sixty (60) days of the Screening Visit date to start baseline 
testing, and no later than two (2) weeks after receiving confirmation of meeting final study 
cohort criteria from the CGA .
Page 16, Schedule of Study Visits and Procedures: Vision Cohort 1 & Vision Cohort 2, states 
tha
Baseline Visit date (defined as the start date of all Baseline testing) must be no later than 
two (2) weeks after receiving confirmation of meeting final study cohort criteria from the 
CGA.
Page 17, Schedule of Study Visits and Procedures: Vision Cohort 3, states that Baseline Visit 
date (defined as the start date of all Baseline testing) must be no later than two (2) weeks 
after receiving confirmation of meeting final study cohort criteria from the CGA.
Page 34, Chapter 3: Baseline Visit, states that 
natural history study will return for a Baseline Visit within sixty (60) days after receiving 
confirmation of meeting 
.
To clarify, participants who enroll into the study cohort will return to the clinic within sixty (60) days 
of the Screening Visit date to start the Baseline Visit. Therefore, Page 13, Protocol Overview/Synopsis, 
Page 16, Schedule of Study Visits and Procedures: Vision Cohort 1 & Vision Cohort 2, and Page 17, 
Schedule of Study Visits and Procedures: Vision Cohort 3 will be amended to indicate that 
within sixty (60) days after receiving confirmation of meeting final study cohort criteria from the 
If this protocol requires substantial changes in the future, the administrative changes
described in this letter will be incorporated into the amended protocol.
Allison Ayala
I agree to the terms defined by the placement of my 
signature in this document
2024-01-09 11:32-05:00

Please inform your institutional review board/independent ethics committee of these changes, as 
required. 
 
If you have any questions, please feel free to contact me via email at aayala@jaeb.org.  
 
Sincerely, 
 
 
 
Allison Ayala, MS 
GYROS Project Director