Wet Macular DegenerationPhase 2NCT05637255
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
A Phase 2 study testing SYL1801 in people with Wet Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Sylentis, S.A. at 16 sites in 3 countries.
Trial summary
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration
- What is being tested?
- SYL1801
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 22 Nov 2022to 19 Dec 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD
- Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening
- Intraretinal or subretinal fluid
- Central Subfield Thickness > 300 µm
Who cannot join
- Pregnant or breastfeeding females or those with a positive pregnancy test.
- Females of childbearing potential who will not use a medically acceptable contraceptive method
- Current, previous chronic or recurrent condition according to the investigator's judgement.
- Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications
- Concurrent disease in the study eye
- Previous treatment with systemic anti-Vascular Endothelial Growing Factor (Anti-VEGF) drugs or pro-VEGF treatments
- Concurrent disease in the study eye, other than AMD
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Czechia8 sites
SYL1801 Investigative Site
Brno, 62500
SYL1801 Investigative Site
Chomutov, 43001
SYL1801 Investigative Site
Frýdek-Místek, 738 01
SYL1801 Investigative Site
Kyjov, 69701
SYL1801 Investigative Site
Liberec, 46063
SYL1801 Investigative Site
Ostrava, 70200
SYL1801 Investigative Site
Prague, 14000
SYL1801 Investigative Site
Prague, 17000
Poland4 sites
SYL1801 Investigative Site
Gdansk, 80-809
SYL1801 Investigative Site
Krakow, 31-070
SYL1801 Investigative Site
Rzeszów, 35-017
SYL1801 Investigative Site
Warsaw, 01-258
Slovakia4 sites
SYL1801 Investigative Site
Bratislava, 85107
SYL1801 Investigative Site
Košice, 04011
SYL1801 Investigative Site
Poprad, 05801
SYL1801 Investigative Site
Žilina
About this study
Official title: A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
- Conditions
- Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration
- Being tested
- SYL1801
- Keywords
- siRNA, oligonucleotide
- Medical subject headings
- Wet Macular Degeneration, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL1801Drug
1 drop in the eligible eye
| Study group | Role | What they receive |
|---|---|---|
| SYL1801 ophthalmic solution Low Dose once daily | Experimental | 42 treatment days Receives: Drug: SYL1801 |
| SYL1801 ophthalmic solution Middle Dose once daily | Experimental | 42 treatment days Receives: Drug: SYL1801 |
| SYL1801 ophthalmic solution High Dose once daily | Experimental | 42 treatment days Receives: Drug: SYL1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Measured: 42 days after first administration
Secondary outcomes (7)
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Measured: 42 days after first administration
Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Measured: Through study completion, up to 42 days
Proportion of subjects within each cohort who needed rescue medication at any point of the study
Measured: Through study completion, up to 42 days
Change from Baseline on flow area on Day 42 after last instillation of the assigned
Optical Coherence Tomography Angiography (OCTA)
Measured: 42 days after first administration
Change from Screening on leakage area on Day 42 after last instillation of the assigned
Fluorescein Angiography
Measured: 43 days after first administration
Change from Baseline on intraocular pressure (IOP)
Tonometry
Measured: 42 days after first administration
Adverse Event Evaluation
Measured: Through study completion, up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start22 Nov 2022
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637255
- Sponsor's protocol ID
- SYL1801_II
- Other IDs
- 2022-000214-34
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
- ClinicalTrials.gov ID
- NCT05637255
- Acronym / sponsor ID
- SYL1801_II
- Conditions
- Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration
- Keywords
- siRNA, oligonucleotide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 5 Dec 2022 (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.
The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.
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 |
|---|---|---|
| SYL1801 ophthalmic solution Low Dose once daily | Experimental | Drug: SYL180142 treatment days |
| SYL1801 ophthalmic solution Middle Dose once daily | Experimental | Drug: SYL180142 treatment days |
| SYL1801 ophthalmic solution High Dose once daily | Experimental | Drug: SYL180142 treatment days |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Active subfoveal or juxtafoveal choroidal neovascularization secondary to AMD
- Best Corrected Visual Acuity (BCVA) between 70-25 letters (ETDRS) at Screening
- Intraretinal or subretinal fluid
- Central Subfield Thickness > 300 µm
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding females or those with a positive pregnancy test.
- Females of childbearing potential who will not use a medically acceptable contraceptive method
- Current, previous chronic or recurrent condition according to the investigator's judgement.
- Concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications
- Concurrent disease 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 |
|---|---|---|
| SYL18011 drop in the eligible eye | Drug | SYL1801 ophthalmic solution High Dose once daily, SYL1801 ophthalmic solution Low Dose once daily, SYL1801 ophthalmic solution Middle Dose once daily |
Primary outcome
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
Time frame: 42 days after first administration
ETDRS chart
7 secondary outcomes
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level
Time frame: 42 days after first administration
Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level
Time frame: Through study completion, up to 42 days
Proportion of subjects within each cohort who needed rescue medication at any point of the study
Time frame: Through study completion, up to 42 days
Change from Baseline on flow area on Day 42 after last instillation of the assigned
Time frame: 42 days after first administration
Change from Screening on leakage area on Day 42 after last instillation of the assigned
Time frame: 43 days after first administration
Change from Baseline on intraocular pressure (IOP)
Time frame: 42 days after first administration
Adverse Event Evaluation
Time frame: Through study completion, up to 42 days
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 13 Apr 2026.
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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.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYL1801 in people with Wet Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Sylentis, S.A. at 16 sites in 3 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 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: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Poland, Slovakia. 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?
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level (time frame: 42 days after first administration). 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 13 Apr 2026.