Wet Age-related Macular DegenerationPhase 3SAHARANCT07816289
Phase 3 Study of Intravitreal OLN324 in Adults With Neovascular (Wet) Age-related Macular Degeneration (nAMD) (OLN324-CP-05)
A Phase 3 study testing OLN324 and Ranibizumab in people with Wet Age-related Macular Degeneration, 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 neovascular (wet) age-related macular degeneration (nAMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- OLN324 and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent
- Be ≥50 years of age
- Treatment-naive nAMD in the study eye with active subfoveal choroidal neovascularization (CNV)
- Have a decrease in vision in the study eye due to nAMD, with best corrected visual acuity of 78 to 24 letters
- 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
- 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 Monthly Intravitreal OLN324 in Adult Participants With Neovascular (Wet) Age-related Macular Degeneration (nAMD)
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 neovascular (wet) age-related macular degeneration (nAMD).
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- OLN324, Ranibizumab
- Keywords
- Ollin, Ollin Biosciences, Inc., nAMD, wet AMD, Neovascular AMD, Age-related macular degeneration, Wet age-related macular degeneration, Neovascular age-related macular degeneration, OLN324, wAMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLN324Drug
OLN324 by intravitreal injection monthly
RanibizumabDrug
Ranibizumab by intravitreal injection monthly
| Study group | Role | What they receive |
|---|---|---|
| OLN324 | Experimental | Not described Receives: Drug: OLN324 |
| Ranibizumab | Active comparator | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA
Changes in BCVA ETDRS letter score from Day 1 to Week 36
Measured: Day 1 to Week 36
Secondary outcomes (3)
Mean change in OCT CST
Difference in the mean change from baseline in OCT CST in the Study Eye between the OLN324 arm and the ranibizumab arm
Measured: Day 1 to Week 12
Change in PED thickness
Difference in the mean change from baseline in PED thickness on OCT in the Study Eye between the OLN324 arm and the ranibizumab arm
Measured: Day 1 to Week 12
Percentage of participants without retinal fluid in the central subfield at Week 12
Difference in the percentage of participants with absence of both IRF and SRF in the central subfield of the Study Eye between the OLN324 arm and the ranibizumab arm
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 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 Wet Age-related Macular DegenerationStudies 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
- 400 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
- NCT07816289
- Sponsor's protocol ID
- OLN324-CP-05
- Acronym
- SAHARA
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 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 11 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 Monthly Intravitreal OLN324 in Adult Participants With Neovascular (Wet) Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT07816289
- Acronym / sponsor ID
- SAHARA / OLN324-CP-05
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- Ollin, Ollin Biosciences, Inc., nAMD, wet AMD, Neovascular AMD, Age-related macular degeneration, Wet age-related macular degeneration, Neovascular age-related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 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
- 11 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 neovascular (wet) age-related macular degeneration (nAMD).
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 |
| Ranibizumab | Active comparator | Drug: Ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of giving signed informed consent
- Be ≥50 years of age
- Treatment-naive nAMD in the study eye with active subfoveal choroidal neovascularization (CNV)
- Have a decrease in vision in the study eye due to nAMD, with best corrected visual acuity of 78 to 24 letters
- Additional inclusion criteria apply
Key exclusion criteria (6 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 monthly | Drug | OLN324 |
| RanibizumabRanibizumab by intravitreal injection monthly | Drug | Ranibizumab |
Primary outcome
Change in BCVA
Time frame: Day 1 to Week 36
Changes in BCVA ETDRS letter score from Day 1 to Week 36
3 secondary outcomes
Mean change in OCT CST
Time frame: Day 1 to Week 12
Change in PED thickness
Time frame: Day 1 to Week 12
Percentage of participants without retinal fluid in the central subfield at Week 12
Time frame: Week 12
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 11 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 Ranibizumab in people with Wet Age-related Macular Degeneration, 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 5 inclusion and 6 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 11 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 36). 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 11 Sep 2026.