ClinicalTrials.gg
CompletedNCT07484074JADEUpdated Mar 19, 2026

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

A Phase 1 interventional study of Faricimab and OLN324 in Diabetic Macular Edema (DME) and Neovascular (Wet) Age-Related Macular Degeneration, sponsored by Ollin Biosciences, Inc.. Completed at 30 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Ollin Biosciences, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2025, 1 year 1 month ago, and no results have been posted to the registry.
  • Registered 1 year after the study started (first participant enrolled Feb 2025, registered Mar 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 645 studies in Macular Degeneration with a site in United States — 85 open to participants now, 128 under way, 24 of them phase 3. Macular Degeneration · United States.

Enrollment
125th of 491
164 · median 55
Started
2025
with 32 others
Phase 1
91 of 645
10 open now
Registered
625th of 645
by date

Among the 645 studies in Macular Degeneration with a site in United States, this one is the 125th largest by enrollment of the 491 interventional ones that give a count, is one of 33 that started in 2025, is one of 91 in phase 1, and was the 625th registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

85 of the 645 studies in Macular Degeneration with a site in United States are open now. Recruiting first, the newest first:

80 more — sign in →

All 85 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 645 studies in Macular Degeneration with a site in United States, or all of them as a file.
02

Study summary

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

Read the detailed description

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)

03

Conditions studied

  • Diabetic Macular Edema (DME)
  • Neovascular (Wet) Age-Related Macular Degeneration

Keywords

  • nAMD
  • wAMD
  • DME
  • AMD
  • Ollin
  • OLN324
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be willing and able to understand the study procedures and the risks involved and provide written 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Active comparator
    faricimab 6mg

    Drug: Faricimab

  • Experimental
    OLN324 2mg

    Drug: OLN324

  • Experimental
    OLN324 4mg

    Drug: OLN324

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Time frame: Week 12 and Week 20

07

Study locations

30 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Oct 2025, 7 months.

Of 60 industry-sponsored phase 1 interventional studies under Macular Degeneration, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 7 months is below that.

Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2026
First posted
Mar 19, 2026
StartActual
Feb 12, 2025
Primary completionActual
Oct 10, 2025
CompletionActual
Dec 9, 2025
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07484074
Responsible party
Sponsor
First posted
Mar 19, 2026
Start date
Feb 12, 2025
Primary completion
Oct 10, 2025
Completion
Dec 9, 2025
Last update
Mar 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: OLN324

Start the discussion