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Completed

NCT Number: NCT07484074

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

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

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Key information

Conditions

Diabetic Macular Edema (DME) Eye Diseases Macular Degeneration Neovascular (Wet) Age-related Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arecibo, Puerto Rico, Arecibo, Puerto Rico

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Faricimab

Drug

Intravitreal Injection

OLN324

Drug

Intravitreal Injection

Primary outcomes

  1. Adverse Events

    Time frame: Week 12 and Week 20

Sponsors and collaborators

Lead sponsor

Ollin Biosciences, Inc.

Industry

Registry information

Official study 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)

Acronym: JADE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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