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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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ClinicalTrials.gov Identifier: NCT05637255
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Neovascular Age-related Macular Degeneration Macular Degeneration Drug: SYL1801 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular AMD
Actual Study Start Date : November 22, 2022
Estimated Primary Completion Date : July 22, 2023
Estimated Study Completion Date : November 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SYL1801 ophthalmic solution Low Dose once daily
42 treatment days
 Drug: SYL1801
1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution Middle Dose once daily
42 treatment days
 Drug: SYL1801
1 drop in the eligible eye
Experimental: SYL1801 ophthalmic solution High Dose once daily
42 treatment days
 Drug: SYL1801
1 drop in the eligible eye


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    ETDRS chart

  2. 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 ]
    ETDRS chart

  3. 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 ]
  4. Change from Baseline on flow area on Day 42 after last instillation of the assigned [ Time Frame: 42 days after first administration ]
    Optical Coherence Tomography Angiography (OCTA)

  5. Change from Screening on leakage area on Day 42 after last instillation of the assigned [ Time Frame: 43 days after first administration ]
    Fluorescein Angiography

  6. Change from Baseline on intraocular pressure (IOP) [ Time Frame: 42 days after first administration ]
    Tonometry

  7. Adverse Event Evaluation [ Time Frame: Through study completion, up to 42 days ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637255


Contacts
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Contact: Regulatory Affairs Department 918047667 info@sylentis.com

Locations
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Czechia
SYL1801 Investigative Site Recruiting
Brno, Czechia, 62500
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Chomutov, Czechia, 43001
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Frýdek-Místek, Czechia, 738 01
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Kyjov, Czechia, 69701
Contact       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Liberec, Czechia, 46063
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Ostrava, Czechia, 70200
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Praha, Czechia, 14000
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Praha, Czechia, 17000
Contact: Regulatory Affairs Department       info@sylentis.com   
Poland
SYL1801 Investigative Site Recruiting
Gdansk, Poland, 80-809
Contact: Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Kraków, Poland, 31-070
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Rzeszów, Poland, 35-017
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Warsaw, Poland, 01-258
Contact: Regulatory Affairs Department       info@sylentis.com   
Slovakia
SYL1801 Investigative Site Recruiting
Bratislava, Slovakia, 85107
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Košice, Slovakia, 04011
Contact: Regulatory affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Poprad, Slovakia, 05801
Contact: Regulatory Affairs Department       info@sylentis.com   
SYL1801 Investigative Site Recruiting
Žilina, Slovakia
Contact: Regulatory Affairs Department       info@sylentis.com   
Sponsors and Collaborators
Sylentis, S.A.
More Information
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Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT05637255    
Other Study ID Numbers: SYL1801_II
2022-000214-34 ( EudraCT Number )
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sylentis, S.A.:
siRNA
oligonucleotide
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases