Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 monthPhase 2a open label study of Fovista¿ (anti-PDGF therapy) administered in combination with anti-VEGF therapy - OPH1008

IVERIC bio, Inc.0 个研究点目标入组 32 人开始时间: 2021年1月19日最近更新: 2021年8月17日

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•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

•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.

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