Neovascular Age-Related Macular Degeneration (AMD) MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: PAN-90806
Product Code: PAN-90806
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: Not available
CAS Number
Sponsors
PanOptica, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A treatment-naïve eye diagnosed with active, pathologic, newly diagnosed subfoveal and/or juxtafoveal with center involvement CNV lesions secondary to neovascular AMD (all lesion subtypes: older classifications include predominantly classic, minimally classic, or occult; newer classifications include Type 1 [sub RPE] and Type 2 [subretinal]) with the following characteristics: • active subfoveal leakage determined by FA; • total lesion area = 4 disc areas (i.e., = 10 mm2; 1 disc area = 2.54 mm2) determined by FA; • =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Lesion Characteristics-Study Eye 3. Significant serous PEDs will be excluded. PEDs will be considered significant if the PED is > 50% of the CNV lesion area or if it is > 400 microns in any diameter. Additional PED characteristics warranting exclusion include a contour that is irregular or corrugated, or evidence of an RPE tear. Borderline PEDs that cannot be clarified for significance after application of these criteria will be excluded if additional assessment by the IRC cannot clearly determine significance or insignificance. 5. The following in the macula: RAP, symptomatic vitreomacular adhesion (sVMA), retinal tear(s)/rip(s), or polypoidal polyps identified by FA and/or SD-OCT (confirmation by ICG angiography is not required). Non-ICG features of polypoidal polyps are well documented in the literature, and include but are not limited to nodular, orange-red RPE elevations observed during ophthalmoscopy, SD-OCT, and/or OCT angiography (OCT-A), neurosensory detachment, and subretinal lipid exudation and hemorrhage. In addition, typically FA evidence of leaking hyperfluorescence is present, which is most often an occult pattern of leakage. Fellow Eye 7. Prior use (within the last 3 months) or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the safety and tolerability of topical ocular PAN-90806 Eye Drops, Suspension;Secondary Objective: Assess the biologic response to topical ocular treatment with PAN-90806 Eye Drops, Suspension; Primary end point(s): Ocular safety and tolerability: 1) Ocular AEs (serious and non-serious) 2) Reductions from baseline in ETDRS BCVA 3) Changes from baseline in IOP 4) Changes from baseline in findings from slit-lamp and fundus examinations 5) Changes from baseline in findings from color fundus photography, fluorescein angiography, and SD-OCT Systemic safety: 6) Non-ocular AEs (serious and non-serious AEs) 7) Changes from baseline in vital signs 8) Changes from baseline in laboratory parameters ; Timepoint(s) of evaluation of this end point: 1) Throughout the study 2 to 5) Screening, Day 1, Week 2, Week 4, Week 8, Week 12, 1 Week post treatment, 1 Month post treatment 6) Throughout the study 7) Screening, Day 1, Week 2, Week 4, Week 8, Week 12, 1 Week post treatment, 1 Month post treatment 8) Screening, Week 12, 1 Week post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Retinal thickness, utilizing center point thickness, center subfield thickness and macular volume by SD-OCT 2) ETDRS BCVA 3) Need for additional treatment with ranibizumab 4) CNV lesion characteristics, such as total area of leakage, total area of CNV lesion, and total area of lesion by FA ; Timepoint(s) of evaluation of this end point: 1 and 2) Screening, Day 1, Week 2, Week 4, Week 8, Week 12 3) Week 2, Week 4, Week 8, Week 12, 1 Week post treatment 4) Screening, Week 4, Week 8, Week 12 | — |
Countries
Czech Republic, Hungary, Latvia, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
PanOptica, Inc.
Outcome results
None listed