Diabetic Macular EdemaPhase 2VERONANCT06099184
Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)
A Phase 2 study testing EYP-1901 and Aflibercept 2Mg/0.05Ml Inj,Oph in people with Diabetic Macular Edema, run by EyePoint Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- EYP-1901 and Aflibercept 2Mg/0.05Ml Inj,Oph
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jan 2024to 24 Oct 2024
- Phase
- Phase 2
- 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
- Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
- Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
- BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
Who cannot join
- Any current or history of ocular disease other than DME
- BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
- Active ocular inflammation or active infection in either eye at Baseline (Day 1).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
EyePoint Investigative Site
Erie, Pennsylvania, 16507
EyePoint Investigative Site
Hagerstown, Maryland, 21740
EyePoint Investigative Site
Lemont, Illinois, 60439
EyePoint Investigative Site
Lynchburg, Virginia, 24502
EyePoint Investigative Site
Phoenix, Arizona, 85020
EyePoint Investigative Site
Reno, Nevada, 89502
About this study
Official title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
Read the detailed description
A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME
- Conditions
- Diabetic Macular Edema
- Being tested
- EYP-1901, Aflibercept 2Mg/0.05Ml Inj,Oph
- Keywords
- DME, EYP-1901, EyePoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYP-1901Drug
Also called Vorolanib
Intravitreal Injection
Aflibercept 2Mg/0.05Ml Inj,OphDrug
Also called Eylea
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| EYP-1901 1343 µg | Experimental | EYP-1901 1343 µg, single dose Receives: Drug: EYP-1901 |
| EYP-1901 2686 µg | Experimental | EYP-1901 2686 µg, single dose Receives: Drug: EYP-1901 |
| Aflibercept | Active comparator | Aflibercept 2 mg/0.05mL solution, single dose Receives: Drug: Aflibercept 2Mg/0.05Ml Inj,Oph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Timing of supplemental injection
Measured: Week 24
Secondary outcomes (1)
Change in best corrected visual acuity (BCVA)
Changes in BCVA
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Jan 2024
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramiro Ribeiro, MD, Study director, EyePoint Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099184
- Sponsor's protocol ID
- EYP-1901-202
- Acronym
- VERONA
- Status last verified
- Sep 2024
- First submitted
- 19 Oct 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT06099184
- Acronym / sponsor ID
- VERONA / EYP-1901-202
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, EYP-1901, EyePoint
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 25 Oct 2023 (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 prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
Detailed description
A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EYP-1901 1343 µg | Experimental | Drug: EYP-1901EYP-1901 1343 µg, single dose |
| EYP-1901 2686 µg | Experimental | Drug: EYP-1901EYP-1901 2686 µg, single dose |
| Aflibercept | Active comparator | Drug: Aflibercept 2Mg/0.05Ml Inj,OphAflibercept 2 mg/0.05mL solution, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
- Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
- BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).
Key exclusion criteria (3 listed)
- Any current or history of ocular disease other than DME
- BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
- Active ocular inflammation or active infection in either eye at Baseline (Day 1).
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 |
|---|---|---|
| EYP-1901Also: VorolanibIntravitreal Injection | Drug | EYP-1901 1343 µg, EYP-1901 2686 µg |
| Aflibercept 2Mg/0.05Ml Inj,OphAlso: EyleaIntravitreal Injection | Drug | Aflibercept |
Primary outcome
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Time frame: Week 24
Timing of supplemental injection
1 secondary outcome
Change in best corrected visual acuity (BCVA)
Time frame: Week 24
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 4 Mar 2025.
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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.
Ramiro Ribeiro, MD study director
EyePoint Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EYP-1901 and Aflibercept 2Mg/0.05Ml Inj,Oph in people with Diabetic Macular Edema, run by EyePoint Pharmaceuticals, Inc. at 6 sites in United States.
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 3 inclusion and 3 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept (time frame: Week 24). 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 4 Mar 2025.