A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD)

Sylentis

Status and phase: Enrolling; Phase 2

Conditions: Macular Degeneration; Wet Macular Degeneration; Neovascular Age-related Macular Degeneration

Treatments: Drug: SYL1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT05637255

SYL1801_II

2022-000214-34 (EudraCT Number)

Details and patient eligibility

About

The goal of this clinical trial is to compare the safety and effect on visual acuity of three different doses of SYL1801 eye drops.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

SYL1801 ophthalmic solution Low Dose once daily

Experimental group

Description:

42 treatment days

Treatment:

Drug: SYL1801

SYL1801 ophthalmic solution Middle Dose once daily

Experimental group

Description:

42 treatment days

Treatment:

Drug: SYL1801

SYL1801 ophthalmic solution High Dose once daily

Experimental group

Description:

42 treatment days

Treatment:

Drug: SYL1801