Diabetic Macular Edema (DME)Phase 1JADENCT07484074
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
A Phase 1 study testing Faricimab and OLN324 in people with Diabetic Macular Edema (DME) and Neovascular (Wet) Age-Related Macular Degeneration, run by Ollin Biosciences, Inc. at 30 sites in 2 countries.
Trial summary
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME), Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- Faricimab and OLN324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 12 Feb 2025to 9 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- If pregnant or breastfeeding
- History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
Abilene, TX
Abilene, Texas, 79606
Arlington, TX
Arlington, Texas, 76012
Austin, TX
Austin, Texas, 78705
Bellaire, TX
Bellaire, Texas, 77401
Dallas, TX
Dallas, Texas, 75231
Fort Myers, FL
Fort Myers, Florida, 33912
Germantown, TN
Germantown, Tennessee, 38138
Glendale, CA
Glendale, California, 91204
Grand Rapids, MI
Grand Rapids, Michigan, 49546
Hagerstown, MD
Hagerstown, Maryland, 21740
Katy, TX
Katy, Texas, 77494
Oak Forest, IL
Oak Forest, Illinois, 60452
Pasadena, CA
Pasadena, California, 91107
Phoenix, AZ
Phoenix, Arizona, 85016
Plano, TX
Plano, Texas, 75075
Reno, NV
Reno, Nevada, 89502
Round Rock, TX
Round Rock, Texas, 78681
Sacramento, CA
Sacramento, California, 95825
San Antonio, TX
San Antonio, Texas, 78240
San Marcos, TX
San Marcos, Texas, 78666
Schertz, TX
Schertz, Texas, 78154
Springfield, OR
Springfield, Oregon, 97477
Saint Petersburg, FL
St. Petersburg, Florida, 33711
The Woodlands, TX
The Woodlands, Texas, 77384
Tulsa, OK
Tulsa, Oklahoma, 74114
Wake Forest, NC
Wake Forest, North Carolina, 27587
Walnut Creek, CA
Walnut Creek, California, 94598
Waterford, CT
Waterford, Connecticut, 06385
Winter Haven, FL
Winter Haven, Florida, 33880
About this study
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)
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)
- Being tested
- Faricimab, OLN324
- Keywords
- nAMD, wAMD, DME, AMD, Ollin, OLN324
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
Intravitreal Injection
OLN324Drug
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| faricimab 6mg | Active comparator | Not described Receives: Drug: Faricimab |
| OLN324 2mg | Experimental | Not described Receives: Drug: OLN324 |
| OLN324 4mg | Experimental | Not described Receives: Drug: OLN324 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Week 12 and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start12 Feb 2025
- Primary completion10 Oct 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ollin Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484074
- Sponsor's protocol ID
- OLN324-CP-01
- Acronym
- JADE
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07484074
- Acronym / sponsor ID
- JADE / OLN324-CP-01
- Keywords
- nAMD, wAMD, DME, AMD, Ollin, OLN324
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ollin Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| faricimab 6mg | Active comparator | Drug: Faricimab |
| OLN324 2mg | Experimental | Drug: OLN324 |
| OLN324 4mg | Experimental | Drug: OLN324 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- If pregnant or breastfeeding
- History of cataract surgery and/or Yttrium-Aluminum Garnet (YAG) for removal of posterior capsular opacification (PCO) within 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaricimabIntravitreal Injection | Drug | faricimab 6mg |
| OLN324Intravitreal Injection | Drug | OLN324 2mg, OLN324 4mg |
Primary outcome
Adverse Events
Time frame: Week 12 and Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Study of CU06-1004 in Patients With Daibetic Macular Edema
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RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
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Active, not recruiting
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RecruitingPhase 2/3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Faricimab and OLN324 in people with Diabetic Macular Edema (DME) and Neovascular (Wet) Age-Related Macular Degeneration, run by Ollin Biosciences, Inc. at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Week 12 and Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.