Back to resultsA Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
Primary Purpose
Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SYL1801
Sponsored by
About this trial
This is an interventional treatment trial for Wet Macular Degeneration focused on measuring siRNA, oligonucleotide
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
- SYL1801 Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SYL1801 ophthalmic solution Low Dose once daily
SYL1801 ophthalmic solution Middle Dose once daily
SYL1801 ophthalmic solution High Dose once daily
Arm Description
42 treatment days
42 treatment days
42 treatment days
Outcomes
Primary Outcome Measures
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Secondary Outcome Measures
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level
ETDRS chart
Proportion of subjects within each cohort who needed rescue medication at any point of the study
Change from Baseline on flow area on Day 42 after last instillation of the assigned
Optical Coherence Tomography Angiography (OCTA)
Change from Screening on leakage area on Day 42 after last instillation of the assigned
Fluorescein Angiography
Change from Baseline on intraocular pressure (IOP)
Tonometry
Adverse Event Evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05637255
Brief Title
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
Official Title
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
July 22, 2023 (Anticipated)
Study Completion Date
November 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration, Neovascular Age-related Macular Degeneration, Macular Degeneration
Keywords
siRNA, oligonucleotide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SYL1801 ophthalmic solution Low Dose once daily
Arm Type
Experimental
Arm Description
42 treatment days
Arm Title
SYL1801 ophthalmic solution Middle Dose once daily
Arm Type
Experimental
Arm Description
42 treatment days
Arm Title
SYL1801 ophthalmic solution High Dose once daily
Arm Type
Experimental
Arm Description
42 treatment days
Intervention Type
Drug
Intervention Name(s)
SYL1801
Intervention Description
1 drop in the eligible eye
Primary Outcome Measure Information:
Title
Change from Baseline on visual acuity on Day 42 after last instillation of the assigned dose level
Description
ETDRS chart
Time Frame
42 days after first administration
Secondary Outcome Measure Information:
Title
Proportion of subjects within each cohort who maintained visual acuity on Day 42 after last instillation of the assigned dose level
Description
ETDRS chart
Time Frame
42 days after first administration
Title
Proportion of subjects within each cohort who gained visual acuity on Day 42 after last instillation of the assigned dose level
Description
ETDRS chart
Time Frame
Through study completion, up to 42 days
Title
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
Title
Change from Baseline on flow area on Day 42 after last instillation of the assigned
Description
Optical Coherence Tomography Angiography (OCTA)
Time Frame
42 days after first administration
Title
Change from Screening on leakage area on Day 42 after last instillation of the assigned
Description
Fluorescein Angiography
Time Frame
43 days after first administration
Title
Change from Baseline on intraocular pressure (IOP)
Description
Tonometry
Time Frame
42 days after first administration
Title
Adverse Event Evaluation
Time Frame
Through study completion, up to 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regulatory Affairs Department
Phone
918047667
Email
info@sylentis.com
Facility Information:
Facility Name
SYL1801 Investigative Site
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Chomutov
ZIP/Postal Code
43001
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Frýdek-Místek
ZIP/Postal Code
738 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Kyjov
ZIP/Postal Code
69701
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Liberec
ZIP/Postal Code
46063
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Ostrava
ZIP/Postal Code
70200
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Praha
ZIP/Postal Code
14000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Praha
ZIP/Postal Code
17000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Gdansk
ZIP/Postal Code
80-809
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Kraków
ZIP/Postal Code
31-070
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Rzeszów
ZIP/Postal Code
35-017
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Warsaw
ZIP/Postal Code
01-258
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Bratislava
ZIP/Postal Code
85107
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Košice
ZIP/Postal Code
04011
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
SYL1801 Investigative Site
City
Žilina
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)
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