A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
JADE
1 other identifier
interventional
164
2 countries
30
Brief Summary
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2025
CompletedFirst Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedMarch 19, 2026
March 1, 2026
8 months
March 9, 2026
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events
Week 12 and Week 20
Study Arms (3)
faricimab 6mg
ACTIVE COMPARATOROLN324 2mg
EXPERIMENTALOLN324 4mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- DME patients must be ≥ 18 years of age, nAMD patients must be ≥ 50 years of age
- Diagnosis of either DME or nAMD. nAMD patients must be treatment naïve. DME patients can be either treatment naïve or treatment experienced
- DME patients must have best corrected visual acuity of 78 to 25 letters
- nAMD patients must have best corrected visual acuity of 80 to 25 letters
You may not qualify if:
- If pregnant or breastfeeding
- History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Phoenix, AZ
Phoenix, Arizona, 85016, United States
Glendale, CA
Glendale, California, 91204, United States
Pasadena, CA
Pasadena, California, 91107, United States
Sacramento, CA
Sacramento, California, 95825, United States
Walnut Creek, CA
Walnut Creek, California, 94598, United States
Waterford, CT
Waterford, Connecticut, 06385, United States
Fort Myers, FL
Fort Myers, Florida, 33912, United States
Saint Petersburg, FL
St. Petersburg, Florida, 33711, United States
Winter Haven, FL
Winter Haven, Florida, 33880, United States
Oak Forest, IL
Oak Forest, Illinois, 60452, United States
Hagerstown, MD
Hagerstown, Maryland, 21740, United States
Grand Rapids, MI
Grand Rapids, Michigan, 49546, United States
Reno, NV
Reno, Nevada, 89502, United States
Wake Forest, NC
Wake Forest, North Carolina, 27587, United States
Tulsa, OK
Tulsa, Oklahoma, 74114, United States
Springfield, OR
Springfield, Oregon, 97477, United States
Germantown, TN
Germantown, Tennessee, 38138, United States
Abilene, TX
Abilene, Texas, 79606, United States
Arlington, TX
Arlington, Texas, 76012, United States
Austin, TX
Austin, Texas, 78705, United States
Bellaire, TX
Bellaire, Texas, 77401, United States
Dallas, TX
Dallas, Texas, 75231, United States
Katy, TX
Katy, Texas, 77494, United States
Plano, TX
Plano, Texas, 75075, United States
Round Rock, TX
Round Rock, Texas, 78681, United States
San Antonio, TX
San Antonio, Texas, 78240, United States
San Marcos, TX
San Marcos, Texas, 78666, United States
Schertz, TX
Schertz, Texas, 78154, United States
The Woodlands, TX
The Woodlands, Texas, 77384, United States
Arecibo, Puerto Rico
Arecibo, 00612-4368, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2026
First Posted
March 19, 2026
Study Start
February 12, 2025
Primary Completion
October 10, 2025
Study Completion
December 9, 2025
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share