Wet form of Neovascular Age-Related Macular Degeneration (AMD) MedDRA version: 20.0 Level: LLT Classification code 10075568 Term: Wet age-related macular degeneration System Organ Class: 100000004853
Conditions
Sponsors
SYLENTIS S.A.U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects need to meet ALL the following criteria: 1. Patient is a male or a female aged = 50 years at screening visit. 2. Have given their written consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom. 3. Presence of active subfoveal CNV (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD evidenced by FA at screening visit confirmed by the central reader. 4. Total area of CNV (including both classic and occult components) encompassed within the lesion and = 50% of the lesion area measured by FA at screening visit as evaluated by the central reader. 5. Central Subfield Thickness >250µm measured by SD-OCT at screening visit as evaluated by the central reader. 6. Presence of intraretinal or subretinal fluid evidenced by SD-OCT suggestive of active CNV secondary to neovascular AMD at screening as evaluated by the central reader. 7. BCVA, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, between 70 and 25 letters (20/40 to 20/320 Snellen equivalent in the study eye) at screening and baseline visit. * Only one eye per patient will be used for effect assessment, as selected by the Investigator and confirmed by the central reader. If both eyes are eligible, the worst eye will be selected, as long as the counter eye does not require immediate treatment. If both eyes are equally affected, the right eye will be selected, as long as the counter eye does not require immediate treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Subjects who meet ANY of the following criteria Non-inclusion criteria related to general health: 1. Pregnant or breastfeeding females or females with a positive pregnancy test at the screening visit. 2. Women of childbearing potential not willing to use a highly effective contraceptive method as defined by protocol. 3. Current, previous chronic or recurrent condition which, according to the Investigator, might impact the interpretation of the study results or put the patient at risk. 4. Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial in the Investigator´s opinion. (List of not permitted medications and procedures in Table 3). Any previous treatment for AMD including anti-VEGF intravitreal injections is prohibited in the study eye. Previous injection in the counter eye is allowed only if the initial treatment course to vision stabilization has been completed and no injections are needed during the course of the study. 5. Clinically significant abnormalities indicating unstable or deteriorating condition of the patient (as determined by the Investigator) in laboratory tests at screening. 6. History of hypersensitivity to any component of the formulation or to ophthalmic diagnostic agents. 7. Concurrent disease in the study eye, other than AMD (e.g., corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could confound interpretation of the results. 8. Prior or current history of diabetic retinopathy, diabetic macular edema, or posterior uveitis, or retinal vein occlusion. 9. Patients who have previously been treated with systemic anti-VEGF drugs or pro-VEGF treatments. 10. Use of contact lenses during the study. 11. Currently participating or having participated in another clinical trial within the 2 months, or 5 study drug half-lives, whichever is longer, prior to inclusion, excluding vitamins or food supplements studies. Non-inclusion criteria related to lesion characteristics: 12. Subretinal haemorrhage in the study eye as confirmed by the central reader, that either involved the center of the fovea, if the size of the haemorrhage is = 1 DA (disc area) in size ; or haemorrhage = 50% of the total lesion area. 13. Subfoveal fibrosis or atrophy in the study eye confirmed by the central reader. 14. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma or pathologic myopia confirmed by the central reader.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Effect of SYL1801 ophthalmic solution on wet AMD disease progression ;Secondary Objective: Effect, tolerabity and safety of SYL1801 opthalmic solution on wet AMD and AE occurrence;Primary end point(s): The primary objective is to evaluate effect on visual acuity of SYL1801 sodium at three doses (5 mg/mL, 25 mg/mL and 50 mg/mL) when administered as 1 drop once a day for 42 days in subjects with neovascular AMD. The primary end point is the change from Baseline (Day 1, 1st administration of IMP) to Visit 3 (after 42 days of treatment) in BCVA score based on ETDRS visual acuity chart.;Timepoint(s) of evaluation of this end point: Day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective: The secondary objective is to evaluate effect on visual acuity and disease progression together with safety of SYL1801 sodium at three doses (5 mg/mL, 25 mg/mL and 50 mg/mL) when administered as 1 drop once a day for 42 days in subjects with neovascular AMD. Secondary endpoints: - Proportion of patients within each cohort who maintained visual acuity, defined as a loss of fewer than 15 letters in BCVA score based on ETDRS chart from Baseline. - Proportion of patients gaining at least 5, 8, 10, and 15 letters in BCVA score based on ETDRS chart from baseline at Visit 3 (Day 43) - Proportion of subjects within each cohort who received rescue medication at Visits 1 through 3. - Change from Baseline within each cohort on the size of CNV (Flow Area) observed with OCT angiography (OCTA) at Visit 3 (Day 43) as determined by the central reader. - Change from Screening within each cohort on the size of CNV (total classic CNV area) and amount of leakage from CNV (leakage area) observed with fluorescein angiography (FA) at Visit 3 (Day 43) as determined by the central reader. - Changes from Baseline (Day 1) within each cohort in the following Optical Coherence Tomography (SD-OCT)-observed biomarkers at Visit 3 (Day 43) as determined by the central reader: o Presence and height/width of the largest cyst in central 1mm of Intraretinal fluid (IRF) o Presence and highest height/width of Subretinal fluid (SRF) o Presence of drusenoid, vascular, or serous Pigment epithelial detachments (PED) o Central subfield thickness (CST) o Disruption of external limiting membrane (ELM) o Disruption of the ellipsoid zone (EZ) Safety endpoints: - Changes from Baseline (Day 1) in IOP, slit-lamp biomicroscopy and dilated ophthalmoscopy at Visit 3 (Day 43). - Changes from Screening in safety laboratory test and vital signs assessment at Visit 3 (Day 43) - Assessment of Adverse events (AEs) occurrence. Exploratory endpoints: - Percentage of subjects w | — |
Countries
Czech Republic, Hungary, Slovakia
Contacts
Public ContactClinical Trials Information
Sylentis S.A.U
Outcome results
None listed