A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324

NCT07484074
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Phase
Phase 1
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Recruitment status
Completed
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Participants
164
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Lead sponsor
Ollin Biosciences, Inc.
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Start date
2025-02-12
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Number of sites
30
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Summary
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
clinicaltrials.gov
Acronym
JADE
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Short title
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
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Official title
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Two Different Formulations of Intravitreal OLN324 in Adult Participants With Either Neovascular (Wet) Age-related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-12-09
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First posted
2026-03-19
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Registry last updated
2026-03-19
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Primary completion date
2025-10-10
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Start date
2025-02-12
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Actual participants
164
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Participants
164
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
30
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Ollin Biosciences, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07484074
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ClinicalTrials.gov ID
NCT07484074
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Adverse Events

    Timeframe: Week 12 and Week 20

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • If pregnant or breastfeeding
  • History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days
Sources for eligibility
clinicaltrials.gov

  • Phoenix, AZPhoenix, United States
  • Glendale, CAGlendale, United States
  • Pasadena, CAPasadena, United States
  • Sacramento, CASacramento, United States
  • Walnut Creek, CAWalnut Creek, United States
  • Waterford, CTWaterford, United States
  • Fort Myers, FLFort Myers, United States
  • Saint Petersburg, FLSt. Petersburg, United States
  • Winter Haven, FLWinter Haven, United States
  • Oak Forest, ILOak Forest, United States
  • Hagerstown, MDHagerstown, United States
  • Grand Rapids, MIGrand Rapids, United States
  • Reno, NVReno, United States
  • Wake Forest, NCWake Forest, United States
  • Tulsa, OKTulsa, United States
  • Springfield, ORSpringfield, United States
  • Germantown, TNGermantown, United States
  • Abilene, TXAbilene, United States
  • Arlington, TXArlington, United States
  • Austin, TXAustin, United States
  • Bellaire, TXBellaire, United States
  • Dallas, TXDallas, United States
  • Katy, TXKaty, United States
  • Plano, TXPlano, United States
  • Round Rock, TXRound Rock, United States

And 5 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)