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Study Resources

Original Protocol_v1.0_26Oct2022
Protocol Amendment 1_v2.0_22Jun2023
Protocol v2.0 Clarification Letter #1_11Aug2023
Protocol Amendment 2_v3.0_17Nov2023
Current Protocol v3.1_19Mar2025
Dear Investigator Letter
Investigator Brochure v11
Investigator Brochure v12
Investigator Brochure v13
Investigator Brochure v13 Addendum 1
Investigator Brochure v14
Investigator Brochure v14 AOR
NOVAI ANX776 IB v2.4
NOVAI ANX776 IB v2.5
NOVAI ANX776 IB v2.6
NOVAI ANX776 IB v2.7
Package Insert 1/2023
Package Insert 10/2023
Vendor Contact List v1.0
Study Contact List v1.0
Study Contact List v1.1
Study Contact List v1.2
Study Contact List v1.3
Study Contact List v1.4
Study Contact List v1.5

Key Study Materials

Participant Screening and Enrollment Log v1.0
Subject ID Log v1.0
Protocol Deviation Log v1.0
Aqueous Humor Inventory Log 24Feb2023
Subject ICF Log v1.0
ICF Document Tracking Log v1.0
Equipment Log-Cumulative v1.0
Equipment Log-Individual v1.0
Equipment Log-Worksheet v1.0
AE Log 10May2023
Clinic Note (word) 11Sep2024
Clinic Note (pdf) 11Sep2024
ConMed Log 10May2023
ConProcedure Log 14Mar2024
Demographics 16May2023
Eligibility Checklist 20Feb2024
EOS Flow 27May2025
Medical History Log 10May2023
Ocular History Log 10May2023
Ocular Procedure Log v1.0
Post Dose FU Call 10May2023
Rescue Criteria Evaluation v1.0
Group 1 Dosing Flow 04Aug2023
Group 2 Dosing Flow 04Aug2023
Group 2 Observation Flow 26Jan2024
IP Admin Sheet_27Aug2024
Rescue Treatment Flow 11Jun2025
Screening Visit Flow 21Sep2023
USV Flow 11Jun2025
Visit Window Template v2.0
IP Admin Sheet 04Aug2023
Eligibility Checklist 10May2023
Eligibility Checklist 20Jul2023
Eligibility Checklist 18Aug2023
EOS-Flow_4Aug2023.docx
EOS Flow 16May2023
Group 1 Dosing Flow 16May2023
Group 2 Dosing Flow 16May2023
Group 2 Observation Flow 10May2023
IP Admin Sheet 10May2023
Screening Visit Flow 16May2023
Screening Visit Flow 04Aug2023
Screening Visit Flow 12Sep2023
USV Flow 16May2023
Visit Window Template v1.0
Clinic Note 16May2023
Clinic Note (word) 21Aug2024
Clinic Note (pdf) 21Aug2024
Clinic Note (word) 23Aug2024
Clinic Note (pdf) 23Aug2024
Rescue Treatment Flow 04Aug2023
USV Flow 04Aug2023
Image Eligibility Assessment v1.0
Image Eligibility Assessment v1.1
Aqueous Humor Shipment Process v1.0
Subject ID Card 31Jan2023

Subject-Related Documents

Early Termination Review Form v1.0
Early Termination Review Form v1.1
Early Termination Review Form v1.2
Early Termination Review Form v1.3

Rescue Treatment Approval Form v1.0
Rescue Treatment Approval Form v2.0
Rescue Treatment Approval Form v2.1
Rescue Treatment Approval Form v3.0
Rescue Treatment Approval Form v3.1
Rescue Treatment Approval Form v3.1_Updated
Rescue Treatment Approval Form v3.2
Rescue Treatment Approval Form v3.3
Rescue Treatment Approval Form v3.4

FDA 1572 Template (superseded)
FDA 1572 Template_23Apr2025 (superseded)
FDA 1572 Template_Apr2025
Financial Disclosure Template 27Oct2022
EMR Checklist Template v2.1
Source Document Location Form Template v1.0
Site Signature Delegation Log v1.0
Monitoring Visit Log v1.0
Protocol Deviation Log v1.0
Site Personnel Training Log Template

SAFETY

Investigator Meeting Slides 30Nov2022
Investigator Meeting Recording 30Nov2022
Medrio Site User Training Session 1
Medrio Site User Training Session 2
Medrio Site User Training Log v1.1
Medrio Site User Training Log v1.0
Visit Window Calculator Training
MAGIC BCVA Manual 10Nov2022
Site Image Secure File Repository Training 05Sep2024

Manuals

Correspondence

Study Training

Fellow Eye Accountability Log v1.0
Study Eye Accountability Log v1.0
Fellow Eye Order Form v1.0
Fellow Eye Order Form v1.1
Fellow Eye Order Form v1.2
Fellow Eye Order Form v1.3
Fellow Eye Order Form v1.4
Fellow Eye Order Form v1.5
Temperature Monitoring Log v1.0
Temperature Excursion Form v1.0
Temperature Excursion Form v1.1
Temperature Excursion Form v1.2
Temperature Excursion Form v2.0
Temperature Excursion Form v2.1
Temperature Excursion Form v2.2
Temperature Excursion Form v2.3