Diabetic Macular Edema (DME)Phase 3GOBINCT07842016
Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-03)
A Phase 3 study testing OLN324 and Aflibercept in people with Diabetic Macular Edema (DME), run by Ollin Biosciences, Inc..
Trial summary
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- OLN324 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Capable of giving signed informed consent
- Be ≥18 years of age.
- Have type 1 or type 2 diabetes mellitus
- Have a decrease in vision in the study eye due to diabetic macular edema (DME), with best corrected visual acuity of 78 to 25 letters
- Have macular edema on OCT with a CST of ≥ 325 µm
- Participants may be either treatment-naïve or previously-treated for DME in their study eye. The number of previously-treated participants is limited.
- Additional inclusion criteria apply
Who cannot join
- Be pregnant or breastfeeding
- History of cataract surgery in the study eye within 90 days of Screening
- Has uncontrolled glaucoma in the study eye
- Has uncontrolled hypertension
- Has had a stroke or myocardial infarction within 180 days
- If in the cohort of previously treated for DME participants, prior treatment with intravitreal bevacizumab, aflibercept, faricimab, ranibizumab, conbercept, or other approved anti-VEGF or Anti-VEGF/Anti-Ang-2 therapies within 90 days of randomization.
- Additional exclusion criteria apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Intravitreal OLN324 in Adult Participants With Diabetic Macular Edema (DME) (GOBI)
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME).
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- OLN324, Aflibercept
- Keywords
- DME, Diabetic Macular Edema, Diabetic Retinopathy, Diabetic Eye Disease, OLN324, Ollin, Ollin Biosciences, Inc.
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLN324Drug
OLN324 by intravitreal injection at protocol-specified dosing intervals
AfliberceptDrug
Aflibercept by intravitreal injection at protocol specified dosing intervals
| Study group | Role | What they receive |
|---|---|---|
| OLN324 | Experimental | Not described Receives: Drug: OLN324 |
| Aflibercept | Active comparator | Not described Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA
Change in ETDRS BCVA eye chart letter score from Day 1 to Week 48.
Measured: Day 1 to Week 48
Secondary outcomes (5)
Mean change in OCT CST in the Study Eye from baseline at Week 20
Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the aflibercept arm
Measured: Day 1 to Week 20
Percentage of participants with absence of DME in the Study Eye at Week 20
Difference in the percentage of participants with absence of DME in the Study Eye between the OLN324 arm and the aflibercept arm
Measured: Day 1 to Week 20
Time to DME resolution in the Study Eye
Difference in the time to first DME resolution in the Study Eye
Measured: Enrollment through study completion, an average of 2 years
Mean change in OCT CST in the Study Eye from baseline at Week 48
Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the aflibercept arm
Measured: Day 1 to Week 48
Percentage of participants with absence of DME in the Study Eye at Week 48
Difference in the percentage of participants with absence of DME in the Study Eye between the OLN324 arm and the aflibercept arm
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2029 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ollin Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842016
- Sponsor's protocol ID
- OLN324-CP-03
- Acronym
- GOBI
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-masked, Multicenter, Active Comparator-controlled Trial to Investigate the Efficacy and Safety of Intravitreal OLN324 in Adult Participants With Diabetic Macular Edema (DME) (GOBI)
- ClinicalTrials.gov ID
- NCT07842016
- Acronym / sponsor ID
- GOBI / OLN324-CP-03
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- DME, Diabetic Macular Edema, Diabetic Retinopathy, Diabetic Eye Disease, OLN324, Ollin, Ollin Biosciences, Inc.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Ollin Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 25 Sep 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.
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with 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
- 2
| Arm | Type | Receives |
|---|---|---|
| OLN324 | Experimental | Drug: OLN324 |
| Aflibercept | Active comparator | Drug: Aflibercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Capable of giving signed informed consent
- Be ≥18 years of age.
- Have type 1 or type 2 diabetes mellitus
- Have a decrease in vision in the study eye due to diabetic macular edema (DME), with best corrected visual acuity of 78 to 25 letters
- Have macular edema on OCT with a CST of ≥ 325 µm
Key exclusion criteria (7 listed)
- Be pregnant or breastfeeding
- History of cataract surgery in the study eye within 90 days of Screening
- Has uncontrolled glaucoma in the study eye
- Has uncontrolled hypertension
- Has had a stroke or myocardial infarction within 180 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 |
|---|---|---|
| OLN324OLN324 by intravitreal injection at protocol-specified dosing intervals | Drug | OLN324 |
| AfliberceptAflibercept by intravitreal injection at protocol specified dosing intervals | Drug | Aflibercept |
Primary outcome
Change in BCVA
Time frame: Day 1 to Week 48
Change in ETDRS BCVA eye chart letter score from Day 1 to Week 48.
5 secondary outcomes
Mean change in OCT CST in the Study Eye from baseline at Week 20
Time frame: Day 1 to Week 20
Percentage of participants with absence of DME in the Study Eye at Week 20
Time frame: Day 1 to Week 20
Time to DME resolution in the Study Eye
Time frame: Enrollment through study completion, an average of 2 years
Mean change in OCT CST in the Study Eye from baseline at Week 48
Time frame: Day 1 to Week 48
Percentage of participants with absence of DME in the Study Eye at Week 48
Time frame: Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OLN324 and Aflibercept in people with Diabetic Macular Edema (DME), run by Ollin Biosciences, Inc..
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Varun Malhotra, MD (737-330-1517, ollinclinops@ollin.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BCVA (time frame: Day 1 to Week 48). 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 25 Sep 2026.