Wet Age-related Macular DegenerationPhase 1NCT04747197
First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)
A Phase 1 study testing EYP-1901 in people with Wet Age-related Macular Degeneration, run by EyePoint Pharmaceuticals, Inc. at 11 sites in United States.
Trial summary
Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD) 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?
- EYP-1901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 Jan 2021to 11 May 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
- Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
- Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
- Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).
Who cannot join
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Subfoveal fibrosis or scarring >50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
- Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
- Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
- Active intraocular inflammation (grade trace or above) in the study eye.
- History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
Show all 9Show fewer
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
EyePoint Investigational Site
Abilene, Texas, 79606
EyePoint Investigative Site
Asheville, North Carolina, 28803
EyePoint Investigational Site
Austin, Texas, 78705
EyePoint Investigational Site
Beverly Hills, California, 90211
EyePoint Investigational Site
Melbourne, Florida, 32901
EyePoint Investigative Site
Mountain View, California, 94040
EyePoint Investigational Site
Oxnard, California, 93036
EyePoint Investigational Site
Philadelphia, Pennsylvania, 19107
EyePoint Investigational Site
Phoenix, Arizona, 85053
EyePoint Investigational Site
Springfield, Massachusetts, 01107
EyePoint Investigational Site
St. Petersburg, Florida, 33711
About this study
Official title: A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- EYP-1901
- Keywords
- wAMD, EYP-1901, EyePoint, DAVIO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYP-1901Drug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 440 ug, single dose | Experimental | EYP-1901 440 ug, single dose Receives: Drug: EYP-1901 |
| 2060 ug, single dose | Experimental | EYP-1901 2060 ug, single dose Receives: Drug: EYP-1901 |
| 3090 ug, single dose | Experimental | EYP-1901 3090 ug, single dose Receives: Drug: EYP-1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
Measured: Week 48
Secondary outcomes (2)
Change in best corrected visual acuity (BCVA) by EDTRS
Mean change from Baseline in BCVA in the Study Eye
Measured: Baseline, Week 48
Mean change in central subfield thickness (CST)
Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye
Measured: Baseline, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Jan 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747197
- Sponsor's protocol ID
- EYP-1901-001
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel S, Storey PP, Barakat MR, Hershberger V, Bridges WZ Jr, Eichenbaum DA, Lally DR, Boyer DS, Bakri SJ, Roy M, Paggiarino DA. Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration. Ophthalmol Sci. 2024 Apr 9;4(5):100527. doi: 10.1016/j.xops.2024.100527. eCollection 2024 Sep-Oct.
PubMed 38881599
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
- ClinicalTrials.gov ID
- NCT04747197
- Acronym / sponsor ID
- EYP-1901-001
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- wAMD, EYP-1901, EyePoint, DAVIO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 10 Feb 2021 (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.
Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 440 ug, single dose | Experimental | Drug: EYP-1901EYP-1901 440 ug, single dose |
| 2060 ug, single dose | Experimental | Drug: EYP-1901EYP-1901 2060 ug, single dose |
| 3090 ug, single dose | Experimental | Drug: EYP-1901EYP-1901 3090 ug, single dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
- Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
- Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
- Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).
Key exclusion criteria (9 listed)
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Subfoveal fibrosis or scarring >50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
- Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
- Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
- Active intraocular inflammation (grade trace or above) in the study eye.
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-1901Intravitreal injection | Drug | 2060 ug, single dose, 3090 ug, single dose, 440 ug, single dose |
Primary outcome
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Time frame: Week 48
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
2 secondary outcomes
Change in best corrected visual acuity (BCVA) by EDTRS
Time frame: Baseline, Week 48
Mean change in central subfield thickness (CST)
Time frame: Baseline, Week 48
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 Jul 2023.
- Derived from this study: PubMed 38881599Patel S, Storey PP, Barakat MR, Hershberger V, Bridges WZ Jr, Eichenbaum DA, Lally DR, Boyer DS, Bakri SJ, Roy M, Paggiarino DA. Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration. Ophthalmol Sci. 2024 Apr 9;4(5):100527. doi: 10.1016/j.xops.2024.100527. eCollection 2024 Sep-Oct.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EYP-1901 in people with Wet Age-related Macular Degeneration, run by EyePoint Pharmaceuticals, Inc. at 11 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 4 inclusion and 9 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747197, which also lists 1 linked publication.
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 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.