Subfoveal choroidal neovascularization secondary to 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 MedDRA version: 20.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Fovista
Product Code: E10030
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pegpleranib sodium
CAS Number: 1449390-73-1
Current Sponsor code: E10030
Concentration uni
Sponsors
IVERIC bio, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: OPHTHALMIC INCLUSION CRITERIA: The following inclusion criteria apply to the study eye: - Best corrected visual acuity in the study eye between 20/40 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization. Presence of Subfoveal CNV by FA or OCTA, or ICG or OCT (presence of fluid and hypereflective consistent with CNV). GENERAL INCLUSION CRITERIA: - Subjects of either gender aged =50 years. - Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication. - Provide written informed consent. - Ability to comply with study and follow-up procedures and return for all trial visits. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: OPHTHALMIC EXCLUSION CRITERIA: - Subjects with atrophy or scar within 1 disc area (DA) of the center of the fovea are excluded. - Prior thermal laser in the macular region, regardless of indication. - Ocular or periocular infection in the past twelve (12) weeks. - History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant. - Previous therapeutic radiation in the region of the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and biomarker responses of various regimens of Fovista¿ when administered in combination with anti-VEGF agents, in treatment na¿ve and treatment experienced neovascular AMD subjects.;Secondary Objective: NA;Primary end point(s): Biomarker Imaging Endpoints: Modalities: (Fluorescein Angiography (FA), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), Optical Coherence Tomography Angiography (OCTA) - CNV and/or CNV complex analysis with respect to area and/or volume and/or flow. Safety Endpoints: - Severe Visual Acuity Loss (Proportion of subjects with >15 letter loss at Months 12 and 18) - Ophthalmic Adverse Events (AEs) - Systemic Adverse Events (AEs) - Laboratory data (blood: hematology, renal function, hepatic function and electrolytes). ;Timepoint(s) of evaluation of this end point: Following Month 0-8, 10-14 and 16-18 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
France, Italy
Contacts
Public ContactSatish C Tripathi
OPHTHOTECH CORPORATION
Outcome results
None listed